Thrombocytopenia
Conditions
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.
Interventions
Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7
OTHERPlacebo
Placebo will be given in a similar manner
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POD 7 Platelet Counts | 7th post-operative day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pre-operative platelet counts | 1 day prior to surgery |
Countries
India
Contacts
Primary ContactAnubhav Harshit Kumar, MCh
Outcome results
None listed