Trial · NCT07899853
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | one-year cumulative incidence of biliary complications | 1 year | Death censored incidence of biliary complications including biliary anastomotic strictures, post-transplant cholangiopathy and biliary leakages, all that necessitate intervention |
| Secondary | cost-effectiveness | 5 year | QALYs derived from EQ-5D-5L questionnaire measured at six time points: waitlist registration, and at six weeks, three, six, twelve and twenty-four months post-transplantation. If aNRP is estimated to lead to higher costs as well as better health outcomes or to lower costs and worse health outcomes, an incremental cost-effectiveness ratio (ICER) will be calculated (costs per QALY gained or savings per QALY lost). If not, one treatment will be considered dominant. As aNRP perfuses multiple organs at once, the overall costs per procedure and subsequent transplantations will be researched. |
| Secondary | Post transplant cholangiopathy rate | 1 year | Narrowing or irregularity of intra- or extra-hepatic donor bile duct excluding the biliary anastomosis leading to clinical symptoms or laboratory derangements in the absence of hepatic artery thrombosis for which an invasive intervention is required. |
| Secondary | patient QOL | 2 year | Health-Related Quality of Life via PROMIS questionnaire: Patient-Reported Outcomes Measurement Information System, that assesses seven core health domains using 4-item short form items plus one pain intensity item (scale 0-10, with 10 worse outcome). |
| Secondary | Patient mortality | 1 year | Recipient death |
| Secondary | Graft loss | 1 year | Failure of the liver allograft requiring either re-transplantation or leading to recipient mortality. |
| Secondary | post-transplant overall complications | 1 year | Also including vascular complications (hepatic artery and portal vein thrombosis) And complications graded as Clavien Dindo =\> 3a, and the comprehensive complication index |
| Secondary | duration of hospital and ICU stay | 1 year | In days |
| Secondary | Environmental Demand | 1 year | Environmental Demand: Measured in global hectares (gha). Converts all physical inputs (Greenhouse Gas Emissions: Measured in kg CO₂e, Electricity: Measured in kWh an Consumables \& Waste: Measured in kg of waste and liters (L) of fluids) into the total biophysical land area required to support each distinct protocol. |
| Secondary | Liver utilization rate | 1 year | How many livers are transplanted and still functioning from organ offer to 1 year post transplantation. It takes in account the acceptance rate, discard rate, transplant rate and 1-year survival. |
| Secondary | Postoperative intra-abdominal bleeding | During index in-hospital stay, on average 9 days | Clinically significant bleeding event requiring percutaneous or surgical re-intervention |
| Secondary | Presence of post reperfusion syndrome | During transplantation | A drop in mean arterial pression ≥30% from the baseline for at least 1 min and within 5 min from reperfusion |
| Secondary | Need for renal replacement therapy | During index in-hospital stay, on average 9 days | Any extracorporeal therapy to supplement or replace renal function that was not present before transplant |
| Secondary | Intervention rates | 1 year | e.g. MRCP, ERCP and percutaneous transhepatic cholangiography drainage |
| Secondary | Reoperation rate | 1 year | Number of reoperations |
| Secondary | Early Allograft Failure Simplified Estimation Score | 10 days post operative | EASE = -0.602 + 0.044\*(MELD at transplant) + 0.065\*(number of PACKED RED BLOOD CELL transfused units during surgery) + 2.567 (if arterial or portal thrombosis during days 1-10) + 0.000534\*(AUC ln AST in POD1,2,3,7,10)2 - 0.093\*(AUC ln PLT in POD1,3,7,10) - 7.766\*(slope ln PLT in POD1,3,7,10) + 0.795\*(slope ln billirubin in POD1,3,7,10) - 0.402 (if center volume ≥70 cases per year). Five EASE risk groups for graft and patient survival were defined as follows: (1) risk group 1: EASE score \< -3.43; (2) risk group 2: -3.43 ≤ EASE score ≤ -1.26; (3) risk group 3: -1.25 ≤ EASE score ≤ -0.75; (4) risk group 4: -0.74 ≤ EASE score ≤ -0.01 (5) risk group 5: 0 ≤ EASE score ≤ 5. Risk group 5 is the worse outcome. |
| Secondary | Retransplantation rate | 1 year | Failure of the liver allograft requiring explant and replacement with an alternative liver graft |
| Secondary | Primary non function rate | 14 days | Graft loss, re-transplantation, or patient death within 14 days of initial transplantation not secondary to hepatic artery thrombosis, biliary complication, recurrent disease or acute rejection. |
| Secondary | Anastomotic stricture | 1 year | Localized narrowing of the biliary anastomosis between the donor and recipient bile ducts for which an invasive intervention is required. |
| Secondary | Bile leak | 1 year | Extra-luminal escape of biliary contents that requires invasive intervention (percutaneous or surgical) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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