Feb 13, 2022
608.1 Donor Acceptance Criteria for URMC HTC SARS-CoV-2 / COVID-19 Cases
- 1University of Rochester Medical Center
- Human BioMolecular Atlas Program (HuBMAP) Method Development Community
- LungMap2 Consortium
Protocol Citation: Gloria S Pryhuber 2022. 608.1 Donor Acceptance Criteria for URMC HTC SARS-CoV-2 / COVID-19 Cases. protocols.io https://dx.doi.org/10.17504/protocols.io.b4zpqx5n
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it’s working
Created: February 13, 2022
Last Modified: February 13, 2022
Protocol Integer ID: 58127
Keywords: SAR-CoV-2, Donor Lung, Organ Recovery
Funders Acknowledgements:
NIH Biorepository for INvestigation of Diseases of the Lung (BRINDL) - Phase II
Grant ID: 5 U01 HL148861-02
NIH: COVID Supplemental - Biorepository for INvestigation of Diseases of the Lung (BRINDL)
Grant ID: 3 U01HL148861-02S1
NIH HuBMAP:KULMAP: Human Kidney, Urinary Tract and Lung Mapping Center
Grant ID: 1 U54 HL145608-03
Abstract
Purpose and Scope of the Procedure
- Standardize process for receiving lung donations for COVID-19 studies
- Scope: Coordination of screening, acceptance and receipt of tissue for research program
Principles
- Lung donations rejected for transplantation can be used to understand human lung structure and development, ultimately to improve care of patients with lung disease
- Rapid, standardized and safe processing of SARS-CoV2 infected human tissue requires coordination of a team of staff, materials and attention to protocols
- See BSL2+ Safety Protocol (616.1, 617.1 URMC HTC BSL2+ Lung Tissue Protocols)
- Rapid processing is required to maintain the tissues in a state as close to state at death as possible
Guidelines
Safety and Regulatory Considerations:
- Needs and Privacy of donating family should be respected at all times
- Consent for tissue donation for research should be freely given
- Proper consent process will be assured.
- Organs and biospecimens should be shipped safely and expeditiously
- Shipping will meet the minimum requirement for dangerous goods under 49 CFR 172.700 and IATA 1.5.
Materials
Contact Information for Referral Groups
NDRI - https://ndriresource.org/for-researchers
IIAM - https://iiam.org/researchers
Seattle HTC – Dr. Gail Deutsch
Review Case: accept or decline based on eligibility
Review Case: accept or decline based on eligibility
Take referral call or BRINDL screening report
Start Case Record in BRINDL Inventory Screening Log
Review Eligibility Criteria
Inclusion Criteria
1.Gestational age >/= 22 0/7 weeks and live born
2.Age < 99 completed years of age
3.Known time of death
3.1.Priority to donors after declaration of brain death by clinical care team, if appropriate, and planned recovery with minimal WIT
3.2.Death in hospital (ex. delivery room, NICU, PICU, Emergency or Operating Room)
3.3.Known time of death prior to arrival in referral hospital
3.4.Warm Ischemia Time (WIT) prior to organ cooling as short as possible;
may accept up to 6 hours, max of 12 hours in unusual circumstance
4.Sample is to be lung unable to place for transplantation, biopsy of lung to be used for transplant or explanted diseased lung at transplant.
5.Bystander normal tissue from lung resection, less preferred
6. Disease/Exposure: Type II diabetes, current smoker, hypertension noted and accepted with limitations
7. Evidence of acute respriatory failure (PaO2/FiO2 </= 300) due to pneumonia/ARDS or other cause acceptable if associated with COVID-19 disease or appropriate comparative non-COVID-19 disease
8. Correctly completed consent by donor, or authorization by next of kin, for donation for research
Exclusion criteria
1.Warm Ischemia Time Unknown or > 12 hours
2.Infection with high-level organism (Category A) representing risk for processing and shipment.
3.Disease/Exposure exclusions: cystic fibrosis, heavy tobacco or alcohol abuse
4.Evidence of significant lung trauma
Priority acceptance
1.Known lung disease – primary or secondary lung disease due to SARS-CoV-2
2.Normal lungs for comparison to SARS-CoV-2 infections
3.Secondary disease following documented SARS-CoV-2 infection with potential attribution to that infection, such as unexpected pulmonary or brain thrombosis. History and evaluation for diagnoses must be available.
Requested processing protocol for Donation following Brain Death Declaration (DBD)
Requested processing protocol for Donation following Brain Death Declaration (DBD)
Organ Procurement Organization Recovery Team prepares for organ recovery as consistent with organ transplant protocol with cross clamp and in situ cold flush body cooling with minimal warm ischemic time.
Includes flush with UW/SPS-1, HTK or similar organ transplant buffer, until solution runs clear
Recover 1-2 Whole Lung(s) en bloc with at least the lower 1/3 of the trachea.
Complete a minimum back-table lung flush with transplant buffer of 500ml into the pulmonary artery and 500ml into the pulmonary vein.
Do not flush with saline.
Do not wrap in surgical towel.
Staple, clamp, or tie the trachea closed prior to shipping.
Place Lung(s) in a Specimen Bag and submerge with chilled UW/SPS-1 or HTK. Triple bag the tissue.
If available, recover the Whole Thymus.
Place in a conical tube/specimen cup filled with chilled UW/SPS-1 or HTK.
If available, recover at least 3 cm x 3 cm x 3 cm of Spleen.
Place in a Specimen Bag or a Rigid Container filled with chilled UW/SPS-1 or HTK.
If available, recover a 10 CC sample of Blood in a Blood Tube - Green Top (Heparin).
Immediately following recovery, invert the tube several times to mix with the anticoagulant.
Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
Requested processing protocol for Donation following Cardiac Death /Arrest(DCD)
Organ Procurement Organization / Recovery Team prepares for organ recovery as quickly following Cardiac Arrest while in comfort care as authorized by next of kin.
Remainder of organ / tissue recovery should be as consistent with organ transplant protocol (section above) as possible.
Includes organ flush with UW/SPS-1 or HTK until solution runs clear.
While warm ischemic time is to be minimized, tissues may be accepted up to 6 hours WIT, 12 hours in unusual circumstances where disease is rare and research critical
Times of cardiac death and beginning of cold perfusion of organ or cross clamp is to be recorded and reported with Metadata
Preparation for Shipping
Preparation for Shipping
Recovery Team to package and ship such as to meet requirements of 49 CFR 172.700 and IATA 1.5.
Shipment is to reach HTC within 24 hours of recovery.
Label each Specimen Bag or Rigid Container with project code, tissue, and recovery team donor number.
Place Lung, Thymus, and Spleen tissues in the organ box on wet ice and maintain at 2-8°C until shipment.
The Blood vial should be placed outside the organ box but within the shipping container within a biohazard bag.
Recommend to cut a small well in the Styrofoam container for vial security.
Blood sample should not be immersed or placed in direct contact with wet ice to avoid freezing and loss of WBC viability.
HTC: Track case, arrange for transfer from courier to URMC HTC Processing Lab
Metadata
Metadata
Recovery team to provide clinical metadata to include at minimum:
1.cause and events occurring during hospitalization prior to death,
2.any CPR required prior to determination of death,
3.time of brain death (DBD),
4.time of cardiac arrest (DCD),
5.time of cross clamp and cold flush,
6.donor age
7.gestational age at birth in weeks/days or born full term,
8.demographics and anthropometrics including race and ethinicity, weight, height,
9.medication exposure in hospital,
10.number of days on mechanical ventilation leading up to recovery,
11.most recent ventilator settings and minimum of last arterial blood gas with vent settings and FiO2,
12.recent chest XRay reports including any CT/MRI type imaging,
13.recent bronchoscopy reports,
14.test results of any blood, urine, respiratory tract, including sputum, samples
15.recent CBC,
16.current diagnoses,
17.current serologies (at minimum HepB, HepC, HIV, syphilis, CMV, EBV),
18.past medical history including diagnoses,
19.medications taken at home,
20.history of smoking, vaping, drugs of abuse,
21.COVID-19 immunization and exposure history,
22. results and dates of any viral testing including respiratory viral PCR panels and any confirmatory positive or negative testing for SARS CoV2 infection