N/A
N=321
Remote Ischemic Preconditioning in Neurological Death Organ Donors
Organ Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01515072 ↗Enrolled (actual)
321
Serious AEs
14.4%
Results posted
Jun 2017
Primary outcome: Primary: Number of Organs Recovered Per Donor — 3.79; 3.60 organs recovered per donor — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RIPC (Remote Ischemic Preconditioning) (Other)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Organs Recovered Per Donor |
3.79; 3.60 | 0.38 |
| SECONDARY Number of Organs Transplanted Per Donor |
3.41; 3.31 | 0.70 |
| SECONDARY Change in Vasopressor Score |
-15.60; -6.00 | 0.63 |
| SECONDARY Change in Serum Lactate |
0.12; 0.20 | 0.86 |
| SECONDARY Change in Creatinine Clearance |
0; 0 | 0.55 |
| SECONDARY Change in P:F Ratio |
6.5; 0.05 | 0.55 |
| SECONDARY Change in Dynamic Compliance |
2.30; 1.20 | 0.48 |
| SECONDARY Change in Troponins |
-0.04; -0.09 | 0.04 sig |
| SECONDARY Pulsatile Perfusion Flow |
98.58; 89.42; 105.28; 104.03; 117.98; 94.21 | 0.53 |
| SECONDARY Six Month Hospital Free Survival of All Organ Recipients |
172; 171 | 0.97 |
| SECONDARY Delayed Graft Function (DGF) of Kidney Recipients. |
45; 51; 202; 184 | 0.07 |
| SECONDARY Pulsatile Perfusion Parameters |
0.29; 0.38; 0.25; 0.31; 0.22; 0.33 | 0.006 sig |
Summary
The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes.
Neurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.
Eligibility Criteria
Inclusion Criteria
- Neurological death donors in whom brain death determination is imminent
- First person consent or next of kin consent for research
- Donors >=6 years of age
- Organ recovery not expected within 6 hours of consent.
- Both sexes and ethnicities.
Exclusion Criteria
- Donation after cardiac death donors (DCD)
- Live organ donors
- No first person consent and next of kin decline research consent
- Donor Age < 6 years
- Lower extremity trauma or recent amputation
- Tissue only donors
Data sourced from ClinicalTrials.gov (NCT01515072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.