| CTRI Number |
CTRI/2024/04/066269 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of platelet-improving medicine Romiplostim in Liver Transplant Patient |
|
Scientific Title of Study
|
Assessment of Safety and Efficacy of Romiplostim in Live Donor Liver Transplant Recipients- A Prospective Randomized Open Label Trial |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sudhindran |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita institute of Medical Sciences Kochi |
| Address |
Department of Gastrointestinal Surgery and Solid Organ Transplantation,
Amrita Vishwavidyapeetham,
AIMS Health Science Campus,
Ponekkara P.O.
KOCHI-41
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhi@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju S Nair |
| Designation |
Student |
| Affiliation |
Amrita institute of Medical Sciences Kochi |
| Address |
Department of Gastrointestinal Surgery and Solid Organ Transplantation,
Amrita Vishwavidyapeetham,
AIMS Health Science Campus,
Ponekkara P.O.
KOCHI-41
Ernakulam
KERALA
682041
India |
| Phone |
9207082076 |
| Fax |
|
| Email |
anjusnair546@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sudhindran |
| Designation |
Clinical Professor and Chief Transplant Surgeon |
| Affiliation |
Amrita institute of Medical Sciences Kochi |
| Address |
Department of Gastrointestinal Surgery and Solid Organ Transplantation,
Amrita Vishwavidyapeetham,
AIMS Health Science Campus,
Ponekkara P.O.
KOCHI-41
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhi@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice, Amrita School of Pharmacy
Amrita Nagar, Edappally, Kochi, Kerala 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita School of Pharmacy |
| Address |
Amrita School of Pharmacy,AIMS Healthcare campus, Kochi, Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhindhran S |
Amrita institute of medical sciences and Research Centre |
Room No. 4, Department of GI surgery, Solid organ transplantation and Vascular Surgery,
AIMS health science campus Ponekkara , Kochi, Kerala, 682041
Ernakulam
KERALA |
9388623851
sudhisalini@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIMS,Kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platelet transfusion(SDP/RDP) |
Platelet transfusion(SDP/RDP) |
| Intervention |
Romiplostim, 250mcg subcutameously. Romiplostim may be administered after every 3 days if the platelet count does not go above 40000 platelets per cubic millimeter. |
Romiplostim is a thrombopoietin receptor
agonists (TPO RAs) which activates TPO
receptors on the surface of bone marrow
cells specifically, the
megakaryocytes .This drug is indicated
for the treatment of chronic immune
thrombocytopenia (ITP).
• Romiplostim is more or less proven in
thrombocytopenia following stem cell
transplantation However it’s role in liver
transplantation is not known . The aim of
our study is to assess the efficacy and
safety of romiplostim in live donor liver
transplantation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the age group of 18-65years. Patients with a platelet count below 40000 Patient who signed the informed consent form
|
|
| ExclusionCriteria |
| Details |
Pregnancy, age under 18 or over 65,
ongoing multiple organ failure, antiplatelet therapy,
suspected/ diagnosed heparin-induced thrombocytopenia or innate/acquired thrombophilia. Patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, and aplasia diagnosed on bone marrow.
severe liver cirrhosis with a Child-Pugh score superior to 6, or a medical history of pulmonary embolism/stroke in the previous 6 months were also excluded.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the number of days required for normalization of the platelet count in the romiplostim group compared to the control group following live donor liver transplantation
|
Baseline line(before drug administration)
Post drug administration day 1 to day 14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of thrombosis in the portal vein, hepatic vein & and hepatic artery in both groups.
To quantify and analyse the platelet-derived growth factor, hepatocyte growth factor and vascular endothelial growth factor in romiplostim and control group.
The necessity to temporarily suspend the use of antimetabolite drugs such as mycophenolate mofetil or azathioprine following transplantation in both groups.
Comparison of the number of platelet transfusions required in romiplostim & and control group
To compare the occurrence of early allograft dysfunction.
To compare the cost-effectiveness between both groups
|
within 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="24"
Months="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Following liver transplantation,
thrombocytopenia is the common
accompaniment within 0-5 days. Recovery
to normalcy may take over 2-3 weeks in
60% of patients. Thrombocytopenia
during this period may lead to bleeding
from the operated or remote sites such as the brain.
• Additionally, it is thought that
thrombocytopenia has a propensity to
exaggerate infection leading to graft
failure, even to mortality. This is because
platelets contain several growth factors,
platelet-derived growth factors, insulin-like growth factors, hepatocyte growth
factors, vascular endothelial growth
factors as well as numerous cytokines. Romiplostim is more or less proven in
thrombocytopenia following stem cell
transplantation However it’s role in liver
transplantation is not known . Our study aims to assess the efficacy and
safety of romiplostim in live donor liver transplantation |