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

Primary Purpose

Thrombocytopenia

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Carica Papaya Leaf Extract
Placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carica Papaya Arm

Placebo Arm

Arm Description

1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.

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

Outcomes

Primary Outcome Measures

POD 7 Platelet Counts

Secondary Outcome Measures

Pre-operative platelet counts
Intra-operative blood loss and transfusion requirements
Incidence of Early allograft dysfunction
Incidence of prolonged post-operative drainage

Full Information

First Posted
April 25, 2022
Last Updated
April 30, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05360134
Brief Title
Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation
Official Title
Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carica Papaya Arm
Arm Type
Experimental
Arm Description
1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.
Intervention Type
Drug
Intervention Name(s)
Carica Papaya Leaf Extract
Intervention Description
Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given in a similar manner
Primary Outcome Measure Information:
Title
POD 7 Platelet Counts
Time Frame
7th post-operative day
Secondary Outcome Measure Information:
Title
Pre-operative platelet counts
Time Frame
1 day prior to surgery
Title
Intra-operative blood loss and transfusion requirements
Time Frame
Day 0
Title
Incidence of Early allograft dysfunction
Time Frame
First 7 days following live donor liver transplant
Title
Incidence of prolonged post-operative drainage
Time Frame
First 14 days following live donor liver transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anubhav Harshit Kumar, MCh
Phone
8860188337
Email
anubhav.pawar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viniyendra Pamecha, FEBS
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Anubhav, MS
Phone
01146300000
Email
anubhav.pawar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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