Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation

Not Applicable

• Conditions: Thrombocytopenia
• Interventions: Other: Placebo; Drug: Carica Papaya Leaf Extract

• Registration Number: NCT05360134
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

This project is a pilot randomized controlled trial aimed at investigating the potential of Carica Papaya Leaf Extract, available in a marketed pill formulation, in increasing platelet counts in live donor liver transplant recipients. Carica Papaya leaf extract has shown positive results in increasing platelet counts in various medical conditions such as Dengue, Immune thrombocytopenic purpura and chemotherapy induced thrombocytopenia. Thrombocytopenia i.e. low platelet counts are a common occurrence in patients with chronic liver disease undergoing live donor liver transplant. It has been observed in previous studies that live donor liver transplant recipients who have persistent thrombocytopenia have significantly worse outcomes as compared to patients who have higher platelet counts. Positive results in this study lead to further studies in assessing the impact of platelet augmentation in live donor liver transplant recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-30
• Last Update Submitted: 2022-04-30
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.

Exclusion Criteria

• Patients who do not consent
• ALF & ACLF
• Pediatric transplant recipients
• Allergic to papaya
• Preoperative platelet counts >75,000/ μL
• Recent history of DVT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.
Carica Papaya Arm	Carica Papaya Leaf Extract	1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.

Primary Outcome Measures

Name	Time	Method
POD 7 Platelet Counts	7th post-operative day

Secondary Outcome Measures

Name	Time	Method
Pre-operative platelet counts	1 day prior to surgery
Intra-operative blood loss and transfusion requirements	Day 0
Incidence of prolonged post-operative drainage	First 14 days following live donor liver transplant
Incidence of Early allograft dysfunction	First 7 days following live donor liver transplant

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India