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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Thrombocytopenia

Treatments: Other: Placebo; Drug: Carica Papaya Leaf Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05360134

ILBS-LDLT-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Carica Papaya Arm

Experimental group

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.

Treatment:

Drug: Carica Papaya Leaf Extract

Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo