F
Washington Hospital Center: Protocol for the Rapid Organ Recovery Program, Transplantation Services*

OVERVIEW

The single greatest factor limiting the number of renal transplants performed today is the size of the donor pool. The number of patients awaiting renal transplantation today is greater than ever, but the size of the donor pool has failed to increase to meet this demand. We have proven that kidneys can be recovered from the non-heart-beating donor (NHBD) and through utilization of unique pulsatile preservation methods verify viability of these organs prior to transplantation. Work in Europe suggests that addition of the NHBD to the pool could increase the number of available kidneys by at least 20 percent.

In the fall of 1993, under the sponsorship of the Medlantic Research Institute (MRI), we hosted a Consensus Conference on the Asystolic Trauma Donor. Expert panels addressed medical, legal, ethical, social, and community concerns raised by our proposed protocol for recovering organs from victims of fatal trauma in the MedSTAR. The conferees concurred with protocol implementation with a variety of recommendations. Chief among which was a community oversight committee.

We have implemented those recommendations and have undertaken the recovery of kidneys from the NHBD for transplantation. However, a variety of research initiatives must continue to explore consent issues, com-

*

Provided courtesy of Jimmy Light, Washington Hospital Center, Washington, D.C. Previously printed in IOM, 2000.



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Organ Donation: Opportunities for Action F Washington Hospital Center: Protocol for the Rapid Organ Recovery Program, Transplantation Services* OVERVIEW The single greatest factor limiting the number of renal transplants performed today is the size of the donor pool. The number of patients awaiting renal transplantation today is greater than ever, but the size of the donor pool has failed to increase to meet this demand. We have proven that kidneys can be recovered from the non-heart-beating donor (NHBD) and through utilization of unique pulsatile preservation methods verify viability of these organs prior to transplantation. Work in Europe suggests that addition of the NHBD to the pool could increase the number of available kidneys by at least 20 percent. In the fall of 1993, under the sponsorship of the Medlantic Research Institute (MRI), we hosted a Consensus Conference on the Asystolic Trauma Donor. Expert panels addressed medical, legal, ethical, social, and community concerns raised by our proposed protocol for recovering organs from victims of fatal trauma in the MedSTAR. The conferees concurred with protocol implementation with a variety of recommendations. Chief among which was a community oversight committee. We have implemented those recommendations and have undertaken the recovery of kidneys from the NHBD for transplantation. However, a variety of research initiatives must continue to explore consent issues, com- * Provided courtesy of Jimmy Light, Washington Hospital Center, Washington, D.C. Previously printed in IOM, 2000.

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Organ Donation: Opportunities for Action munity attitudes, and experimental aspects of organ recovery, training and education. Our goal is to assure that the option of organ donation is available to all potential donor families, successfully recover transplantable organs, and recover costs. Design and Methods Oversight This protocol is subject to the oversight of an advisory committee, as recommended by the consensus conference participants. This committee is composed of community members who have an interest in seeing that the program is sensitive to community needs and concerns. The Community Oversight Committee is comprised of nurses, physicians, morticians, clergy, legal services representatives, D.C. government officials, educators, and local transplant groups. The advisory committee is currently chaired by the Director of the Office of Decedent Affairs (ODA) and reports directly to the Office of Community Affairs of the Medlantic Healthcare Group. This advisory committee meets at least on a quarterly basis and began in December 1993. All policies, protocols, and practices were available for review by the Committee Oversight Committee. Regular reports are submitted to the Institutional Review Board (IRB) for continuing review. Although the Rapid Organ Recovery Program (RORP) does not constitute a research program, we are requesting the same consideration under the existing internal review mechanisms. We feel that because of the nature of the program and the community that we serve, the IRB must be kept apprised of the program’s progression and offer advice or direction as the board deems appropriate. Donor Criteria Potential deceased organ donors will include all patients pronounced cardiac dead in MedSTAR, an ICU or the emergency department at Washington Hospital Center (WHC). The potential donors will have the following acceptability criteria: Patients should generally not be over 60 years of age or younger than 18 years of age (<18 with next-of-kin consent). Exceptions will be made on a case by case basis. Patients must have a known time of death. Patients must not have active, untreated systemic bacterial sepsis at the time of death. Patients must not have documented positive testing for HIV, HBsAg, or HTLV1.

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Organ Donation: Opportunities for Action Patients must not have cancer except primary brain tumors, lip/ skin cancers, in-situ carcinomas. Patients must not be among those classified high risk by the CDC, including homosexual/bisexual males, current I.V. drug abusers, or patients with hemophilia/coagulation disorders. The identity of the patient must be known. In those cases where the identity of the patient is unknown, the Family Advocate will make an assessment of the circumstance of death that will include discussions with the involved law enforcement agency. Line placement pursuant to the provisions of the Anatomical Gift Amendment Act of 1996 will not occur unless a high probability of patient and next-of-kin identification and notification can be accomplished within four hours after the known time of death. ICU Donor Protocol (controlled donors) There are several potential ways to obtain organs from non-heart-beating donors in the intensive care units. Any patient under 60 years old from whom withdrawal of support is anticipated and who is expected to suffer a cardiac death shortly after withdrawal should be considered a potential donor. When such patients seem medically suitable according to the criteria in this document, a member of the primary or critical care term should notify the ODA. After the approval of the responsible intensivist the ODA will contact the Medical Examiners Office (if necessary) and the OPO to evaluate the patient. The OPO coordinator will discuss the potential of organ acceptability with the intensivist. The patient’s attending along with the critical care team will discuss withdrawal of support with the family or person responsible for the patient’s health care decisions. If organs seem acceptable a member of the primary or critical care team will introduce the family to the OPO coordinator who is generally the individual who will discuss the option of organ donation along with the ODA Family Advocate. The family member or other person responsible for the patient’s healthcare decisions may then elect to have organs donated. If consent for organ donation has been obtained, the primary medical team and critical care team will notify the ODA of the impending withdrawal of support. The ODA will communicate with the ROR team and the OPO to coordinate their efforts with the primary or critical care team which will direct the withdrawal process. If the patient dies during or after the withdrawal of support the ROR line placement and preservation protocol will be instituted. A patient will remain in the ICU during this time unless it is determined that the operating room, MedSTAR, or the PACU is the preferred setting.

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Organ Donation: Opportunities for Action To accomplish preservation, abdominal cooling lines will be inserted and femoral artery and vein catheters inserted within the 60 minute time allowance. The kidneys will be flushed with a perfusion solution designed to limit the amount of further ischemic damage. Once cooled, the donor can be maintained up to four hours until an operating room is available and a standard organ recovery can be performed. Fatal Trauma Victim Protocol (uncontrolled donors) The second method for recovering organs from non-heart-beating donors is applicable to patients in MedSTAR or the emergency department who suffer uncontrolled cardiac arrest. In this situation it is imperative that the respective unit physicians pronounce death prior to any intervention from the Transplantation Services Department and that there be a clear delineation of the time of death versus the initiation of organ preservation protocols. Based on recommendations made by the attendees of the Consensus Conference on Trauma Victims and Organ Donation (WHC, MRI, WRTC, 1993), numerous steps have been taken to educate the community about this program. Since appropriate steps have been taken, and with concurrence from the Community Oversight Committee, it has been determined that line placement for the purpose of preserving the option of donation for the next-of-kin is both legal (Anatomical Gift Amendment Act of 1996) and appropriate in the event that the family is not present. If the family is present, the Family Advocate must obtain consent prior to the placement of the cold preservation lines. When a potential donor is identified, the Trauma Fellow, Trauma team leader (R4), trauma nurse, or designee in MedSTAR shall page the in-house Family Advocate through the in-house MedSTAR emergency page system. MedSTAR staff may participate in the ROR Protocol only in a support role to the line placement team. This type of support may include locating supplies and movement of the decedent to a more suitable location for line placement. They may not participate in direct hands-on donor preservation line placement. Placement/Transfer of Potential Rapid Organ Donors Potential ROR donors shall be cared for in MedSTAR or an ICU or the PACU until organ recovery occurs. Under no circumstance should these patients be transferred to a floor to await ROR unless specific arrangements are made between the ICU medical staff and the nursing supervisor covering the ICU.

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Organ Donation: Opportunities for Action Consent The majority of deaths in MedSTAR or an ICU may fall under the jurisdiction of the Medical Examiner for the District of Columbia. The Family Advocate shall assist with notification and must obtain consent from the Medical Examiner’s office prior to initiation of any procedure, should this death fall under their jurisdiction. Regardless of the next-of-kin’s wishes, the Medical Examiner has the right to object to donation of any organs or tissues, if such removal would potentially impact the determination of cause and manner of death. Under no circumstances will any procedure be initiated without the Medical Examiner’s approval. Once the Medical Examiner has agreed to allow intervention, the Family Advocate will immediately notify the Line Placement Team. The Family Advocate shall respond to the MedSTAR unit immediately (they carry a code pager) and determine whether a decedent is a potential rapid organ recovery candidate. This determination will be made in consultation with the attending physician/intensivist. The Family Advocate will then immediately notify the Line Placement Team. A search for the next of kin in conjunction with local authorities will be instituted if a family member cannot be located. The Family Advocate is responsible for offering the option of organ/tissue donation to the decedent’s next-of-kin. The consent will be obtained utilizing the standard Uniform Donor Form according to WHC Standard Practice #583.20 and ODA SP#C.300. Additionally, the decedent’s medical/social history must be obtained from the legal next-of-kin and documented utilizing the standard OPO Medical History Form. A Line Placement Team will be available in-house 24 hours a day to respond to a preservation call. If deemed necessary, the team member will draw 10 ccs of blood and run a STAT HIV screening. Should the potential donor test positive, organ preservation will be discontinued. Two 10cc red top tubes and one lavender top tube of blood will be drawn and labeled. One red top tube will be held for the project coordinator to be sent for virology testing and the second sent to the stat lab for ABO determination, BUN, creatinine and electrolyte levels. The lavender top will also be sent for CBC evaluation. Aerobic and anaerobic blood cultures will also be drawn and sent. The bladder will then be catheterized and a specimen sent for stat urinalysis and urine culture. An additional 3 red top tubes of blood must also be drawn for the Medical Examiners Office along with as many PVC test tubes of urine as possible. All tubes must be labeled with the donor’s name, social security number (if available), medical record number, and the date and time of death. A visual image will be recorded at the medical examiner’s request. The OPO will be advised as soon as possible about the potential donor and the whereabouts of the blood samples. The OPO Coordinator will notify the central donor lab so that arrangements can be made

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Organ Donation: Opportunities for Action for the transport of the samples to that lab for tissue typing serological testing. Line Placement Technique A cooling blanket is placed under the donor as soon as possible and set at the lowest possible setting, as an adjunct to core cooling the donor. Supplies for the cannulation and flushing procedure will be provided by the Line Placement Team. A member of the Line Placement Team places the abdominal lavage lines and cannulates the femoral artery and vein in the following manner: 1. PERITONEAL LAVAGE: Two small incisions in the abdomen shall be made to insert the inflow and outflow peritoneal lavage trocars. A sterile disposable trocar, 1–1.5 cm, provided in the onsite donor kit is then placed through the abdomen into the peritoneum, preferably in the patients left upper quadrant, for infusion of peritoneal lavage. A second modified trocar (with holes in it) and pool suction cannula should be placed in a similar fashion into the right lower quadrant directed towards the pouch of Douglas for outflow. Cold 0.9% saline solution is infused until abdominal distention is noted (usually 4 liters). This tubing will be connected to a sterile submersion pump with heat exchanger. The lavage should be run continuously until organ recovery. Documentation must be maintained according to Standard Operating Procedures regarding the amount, type and flow rates of fluid used in the lavage on the NHBD/MedSTAR Flow Sheet. 2. PERFUSION CATHETER: A femoral cut-down is performed through a vertical incision centered on the inguinal ligament. The femoral artery is isolated and controlled with a 0 silk ligature. An arteriotomy is performed and a Porges Multiple Organ Recovery Balloon Catheter passed to the level of the xiphoid process. The distal balloon is inflated with approximately 15cc of 50% hypaque solution and the catheter withdrawn until it lodges at the aortic bifurcation. The proximal balloon is similarly inflated and a stat abdominal x-ray obtained to confirm proper positioning. The infusion tubing should be connected to the mixed cold I.V. perfusate solution and primed to expel any air in the line. The arterial access point is then connected to the primed infusion tubing, and secured to the patient with a 0 silk suture. IN SITU FLUSH SHOULD BEGIN NOW. The flush solution shall consist of several liters of Viaspan solution, each augmented with: 4 mg Stelazine 40 units insulin 16 mg dexamethasone 20,000 units heparin

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Organ Donation: Opportunities for Action When the effluent is clear, the infusion rate is slowed to a steady drip of about 2cc/minute. 3. EFFLUENT CANNULA: In the same cut-down site utilized for placement of the perfusion catheter, the femoral vein is isolated and controlled with a 0 silk ligature. A venotomy is performed and a marked 22 or 26 fr. 30cc balloon Foley Catheter is inserted to the marking to allow venting for the perfusate solution. This 30cc balloon is to be inflated with approximately 20–30cc of 50% hypaque catheter must be pulled taut to set the balloon at the femoral bifurcation. The catheter should be secured with a 2-0 silk ligature. The venous catheter is connected in a sterile fashion to a 2000cc urine collection bag to collect the venous effluent by gravity only. ALL SUPPLIES NECESSARY FOR CANNULATION AND PERFUSION ARE SUPPLIED IN THE ON-SITE RAPID ORGAN RECOVERY CART. These solutions shall be maintained at 4°C in the refrigerator or igloo cooler until the time of infusion. Pre-mixed solutions shall be stored in the refrigerator located in MedSTAR and should be used only if there is no time to mix them in the lab under sterile conditions. To allow for optimal kidney flush and preservation, the solutions should be infused at 70 mm Hg of pressure. The infusion pressure may be approximated by raising the I.V. pole about one meter above the decedent and/or by providing pressure bags as an adjunct. The Line Placement Team will monitor the flush solutions for continued inflow and outflow. Flow characteristics and other parameters such as intra-abdominal temperature are recorded on the ROR/MedSTAR Flow Sheet. Organ Recovery Organ recovery will not be initiated without consent of the legal next of kin, consistent with current practice. Once preservation attempts are completed and consent for organ/tissue retrieval is obtained, and the recovery surgeon and the Washington Regional Transplant Consortium (WRTC) coordinator are present, the body of the donor will be removed from either the MedSTAR unit or the ICU unit to the operating room. The recovery will be performed using standard technique. Peritoneal lavage will be discontinued at the request of the surgeon. The body will be prepped from the neck to the pubis and draped in the usual fashion. A midline incision is made from the sternal notch (sternal saw required) to the symphysis pubis with bilateral supra umbilical transverse

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Organ Donation: Opportunities for Action extensions through the skin, subcutaneous layer, fascia, and muscle to maximize exposure of abdominal organs. The right colon and small bowel mesentery are then reflected to expose the retro peritoneum from the aortic bifurcation to the renal veins. The abdominal organs will be visually inspected, and if they appear well flushed and cool to the touch, a hepatectomy, pancreatectomy and/or a bilateral en-bloc nephrectomy (as approved by the Medical Examiner and family consent), will be performed as described below. The abdominal cavity and kidneys are packed with iced saline slush. A standard en bloc resection, to remove sections of the inferior vena cava and aorta with both kidneys in continuity is used. The entire gastrointestinal tract, spleen, and inferior portion of the pancreas are mobilized by dividing the celiac axis and the superior mesenteric artery, exposing the entire retroperitoneal region. The inferior vena cava and aorta are clamped below the renal vessels with vascular clamps, and the vessels are divided. Lumbar tributaries are secured with metal clips and are divided. The kidneys and ureters are freed from their surrounding soft tissues. The ureters are divided distally at the iliac artery bifurcation. The suprarenal aorta and inferior vena cava are clamped and divided below the diaphragm. The vessels and kidneys are removed from the surgical field, and the aorta and vena cava stumps are ligated. After removal, the kidneys are moved to the back table and are placed in a saline slush where they are immediately re-flushed with cold (8°C) Viaspan solution. Careful inspection, measurement and separation, are carried out on the back table. Cultures of the abdominal fluid, the ureter tips and the organs and the basin containing sterile slush will be obtained and sent to the microbiology laboratory. A wedge biopsy will be obtained of the removed organs and sent to surgical pathology for both a frozen and permanent section. The kidneys are then placed in the hypothermic pulsatile perfusion machine for transport to the MRI/HUH Organ Perfusion laboratory for monitoring and evaluation. After kidney perfusion has begun, the abdominal lymph nodes and spleen are removed for use in tissue typing. The incision is closed with heavy running suture. A video tape may be made at the request of the Medical Examiner of the initial incision and the recovery. The recovery surgeon will verbally note any pertinent observations. This tape will be labeled with donor name and date and will be sent to the Medical Examiners Office as requested. Finally, other tissues donated (e.g., corneas, heart valves, skin, bone, etc.) by the next-of-kin will be procured by the appropriate tissue agencies. All relevant

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Organ Donation: Opportunities for Action parameters and interventions will be recorded. The OPO on site coordinator will observe the surgical recovery and record the anatomy of the kidneys. Photos of the recovered organs may be taken for documentation purposes. Kidney Preservation The kidneys are placed on a hypothermic pulsatile perfusion machine in the operating room and then transported to the Medlantic Research Institute (MRI)/Howard University Hospital (HUH) Organ Preservation Lab for perfusion and evaluation. The kidneys will be perfused with a commercially available solution modified for the NHBD kidney and used in standard ex-vivo kidney perfusion. Appropriate parameters for kidney function and status such as temperature, flow rates, pH perfusion pressures, and resistances will be measured and recorded over the next four to six hours, to determine organ suitability for transplantation. Patient history prior to injury, hemodynamic parameters prior to death, warm ischemic time, cannulation and flush characteristics, biopsy and perfusion characteristics are used to determine the viability of the kidneys and to assess the potential suitability for transplant. Once the kidneys have been deemed suitable for transplantation by the MRI/HUH Organ Preservation Lab Co-Medical Directors and the OPO Medical Director, the OPO Coordinator will be notified so the kidneys maybe placed as per UNOS policies. Placement will not take place until the kidneys are on pump for a minimum of 6 hours. In the event that one or both of the MRI/HUH Co-Medical Directors are unavailable for consultation, the organ recovery surgeon will be responsible for organ suitability evaluation and communications with the OPO Medical Director. Kidney preservation will be performed according to the MRI/HUH Organ Preservation Lab’s Standard Operating Procedures, under licensure from the District of Columbia Department of Consumer and Regulatory Affairs. Post perfusion photos of the kidneys may be taken for documentation purposes. Community Education One of the most important factors in the success of the Rapid Organ Recovery Program is effective community education. The primary concern of the participants of the 1993 consensus conference was that of community education and awareness of the Rapid Organ Recovery Program. To this end, the Office of Decedent Affairs has planned and conducted more than 30 educational presentations in the community with post presentation evaluations using a survey to assess public attitudes toward the Rapid

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Organ Donation: Opportunities for Action Organ Recovery Program. Media coverage of the program has been extensive. Presentations have been made to the D.C. City Council Members as well as the mayor, all of whom expressed support for the program. A program brochure is made available to potential donor families and the community at large. The brochure has been developed by the community oversight committee. Facilities and Equipment The placement of preservation lines will take place within the WHC. Potential donors will remain in MedSTAR/ICU until operating room time is coordinated. All necessary line placement equipment and supplies are available in a specially designed cart in MedSTAR and each ICU. Organ recovery will take place in a WHC operating room. Kidneys will be placed in the Medlantic Organ Preservation Lab’s perfusion pump while in the OR and transported to the MRI/HUH Organ Preservation Lab for preservation and evaluation. The MRI/HUH OPL is fully equipped and ready to perfuse and evaluate ROR kidneys. No additional equipment is needed. Collaborators/Consultants These costs are reimbursable and are outlined in the OPO billing agreement when organs are recovered and transplanted. Conclusion The recovery of organs from the deceased cardiac donor will clearly increase the supply of available organs for transplantation. It has been shown that the recently deceased cadaver is a medically acceptable source of organs for transplantation. By utilizing this donor source both the number of patients waiting for cadaveric transplantation, and the time these individuals must wait for such a transplant will be reduced. Further, a wider pool of potential matches for those patients with uncommon HLA antigens will be available. In addition, more patients and bereaved families will now have the unique opportunity to gain solace from organ donation. We have, in the past year, shown that kidneys recovered using this technique can be successfully transplanted by our program. Major steps have been taken to insure compliance with the recommendations made by the participants of the Consensus Conference and the community oversight committee. Several other transplant centers are now exploring the possibility of utilizing kidneys from NHBDs. However, only a handful of transplant centers in the U.S. have actually recovered and transplanted kidneys from this donor population.

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Organ Donation: Opportunities for Action All charges incurred in the evaluation and procurement of these kidneys for transplant are paid through an agreement with the OPO either through standard billing mechanisms or direct OPO billing from the Medlantic Research Institute Transplant Research Center. Addendum 2006. While successful in recovering and transplanting kidneys from the uncontrolled donor, the resources needed and the labor intensity eventually could not be sustained as a single center effort. The community accepted the concept of initiating preservation pending consent with appreciation. Consent for organ recovery was obtained in just over 50 percent of the cases. REFERENCES IOM (Institute of Medicine). 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: National Academy Press. WHC (Washington Hospital Center), MRI (Medlantic Research Institute), WRTC (Washington Regional Transplant Consortium). 1993 (October 7–8). Consensus Conference on Trauma Victims and Organ Donation. Consensus Report. Washington, DC: WHC.

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