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A trial to assess the usefullness of platelet rich fibrin in preventing bile leaks following living donor liver transplant.

A pilot study followed by an open labelled randomised controlled trial assessing the role of platelet rich fibrin (PRF) in biliary reconstruction in living donor liver transplantation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047425
Enrollment
160
Registered
2022-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical Health Condition 3: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Application of autologous platelet rich fibrin: Application of autologous platelet rich fibrin in living donor liver transplant. The duration of duct reconstruction is same as the stand

Sponsors

Amrita Institute of Medical Sciences research center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consenting adults undergoing liver transplantation for any liver disease in the department of GI surgery and solid organ transplantation, Kochi.

Exclusion criteria

Exclusion criteria: 1. Deceased donor liver transplant 2. APOLT 3. Re-transplantation 4. Paediatric transplantation 5. Poor PRF formation

Design outcomes

Primary

MeasureTime frame
To assess the difference in bile leak rate by using PRF on biliary anastomosis.Timepoint: 3month outcome—

Secondary

MeasureTime frame
1. To assess the differences in overall outcome by use of the PRF on biliary anastomosis, to be ascertained by the following: a. Hospital stay b. ICU stay c. Vascular complications d. Need for post-operative interventions (percutaneous/endoscopic/surgical) e. Organ space infection f. Occurrence of sepsis g. Antibiotic requirement (change from protocol/increase in duration) h. 3 month mortality 2. To identify predictors for bile leak. 3. To assess the safety in the application of PRF for biliary anastomosis. 4. To determine the optimum speed and time of centrifuge by measurement of platelet concentrate and PDGF of PRF in patients with CLD. 5. To correlate haematological variables with the quality of the coagulum. Any adverse effectsTimepoint: 3month outcome—

Countries

India

Contacts

Public ContactDrShweta Mallick

Amrita Institute of Medical Sciences

shwet.mallick@gmail.com9535066320

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026