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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Drug: Carica Papaya Leaf Extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carica Papaya Arm<br>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<br>* Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7<br>|
| Placebo Comparator: Placebo Arm<br>Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7. | Other: Placebo<br>* Placebo will be given in a similar manner<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |