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

NCT05360134 | Unknown

• 1 other identifier: ILBS-LDLT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• POD 7 Platelet Counts

  7th post-operative day

Secondary Outcomes (4)

• 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

Study Arms (2)

Carica Papaya Arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.

Other: Placebo

Interventions

Carica Papaya Leaf Extract DRUG

Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7

Carica Papaya Arm

Placebo OTHER

Placebo will be given in a similar manner

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Viniyendra Pamecha, FEBS

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

Central Study Contacts

Anubhav Harshit Kumar, MCh

CONTACT

8860188337; anubhav.pawar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 4, 2022
• Study Start: January 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)