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

Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Carica Papaya Leaf Extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anubhav Harshit Kumar, MCh; Phone Number: 8860188337; Email: anubhav.pawar@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Anubhav, MS; Phone Number: 01146300000; Email: anubhav.pawar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Carica Papaya Arm; 1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.	Drug: Carica Papaya Leaf Extract; Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7
PLACEBO_COMPARATOR: Placebo Arm; Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.	Other: Placebo; Placebo will be given in a similar manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
POD 7 Platelet Counts	7th post-operative day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Viniyendra Pamecha, FEBS, Institute of Liver & Biliary Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (ACTUAL): May 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: ILBS-LDLT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No