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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360134
• Other study ID #: ILBS-LDLT-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Anubhav Harshit Kumar, MCh
• Phone: 8860188337
• Email: anubhav.pawar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

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

Other:
• Placebo
Placebo will be given in a similar manner

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POD 7 Platelet Counts		7th post-operative day
Secondary	Pre-operative platelet counts		1 day prior to surgery
Secondary	Intra-operative blood loss and transfusion requirements		Day 0
Secondary	Incidence of Early allograft dysfunction		First 7 days following live donor liver transplant
Secondary	Incidence of prolonged post-operative drainage		First 14 days following live donor liver transplant