| CTRI Number |
CTRI/2025/12/099724 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Hypovolemic Phlebotomy in Living Donor Liver Transplant |
|
Scientific Title of Study
|
Intraoperative Phlebotomy in Living Donor Liver Transplant- Means to Minimize Blood Transfusion: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Gokula |
| Designation |
Consultant |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Liver Transplant and GI Anesthesia
Medanta, The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
7579160753 |
| Fax |
|
| Email |
paachuG@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Gokula |
| Designation |
Consultant |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Liver Transplant and GI Anesthesia
Medanta, The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
7579160753 |
| Fax |
|
| Email |
paachuG@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Gokula |
| Designation |
Consultant |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Liver Transplant and GI Anesthesia
Medanta, The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
7579160753 |
| Fax |
|
| Email |
paachuG@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prachi Gokula |
| Address |
Department of liver Transplant and GI Anesthesia
Medanta The Medicity
Gurugram
Haryana
India |
| Type of Sponsor |
Other [Non funded study] |
|
|
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 Prachi Gokula |
Medanta, The Medicity |
Medanta- The Medicity
CH Baktawar Singh Rd
Medicity, Islampur Colony, Sector 38
Gurgaon
HARYANA |
07579160753
paachuG@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70||Alcoholic liver disease, (2) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (3) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
patients who will not undergo intraoperative phlebotomy |
| Intervention |
Controlled Hypovolemic phlebotomy |
Patients who will undergo controlled hypovolemic phlebotomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Adult patients aged between 18-65years planned to undergo living donor liver transplant. |
|
| ExclusionCriteria |
| Details |
•Patients who refuse to consent to participate in the study.
•Patients aged less than 18years of age.
•Patients of acute liver failure
•Patients planned for re-transplantation.
•Patients planned for combined procedure (SLKT, LT+CABG)
•Patients with preoperative haemoglobin less than 7.0 gm/dl
•Patients with EF less than 50%
•Patients with chronic kidney disease, eGFR less than 30ml/min/1.73m2 MDRD, H/O renal replacement therapy within last two weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare intraoperative red cell transfusion requirements (measured in units) between the groups. |
• intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
• Intraoperative fluid requirement [Crystalloids (ml); Colloids (ml) and 25% Albumin(ml)]
• Vasopressor requirement (Noradrenaline- mcg/kg/min and Vasopressin- total units)
• Incidence of postoperative renal dysfunction (KDIGO criteria- on POD1, POD3 and POD7)
• Evaluate pulmonary outcomes (duration of mechanical ventilation, pleural effusion requiring drainage within 72 hours postoperatively) between the groups.
|
fluid and Vasopressor requirement- intraoperative period
incidence of AKI- 7 days
pulmonary outcomes- 3 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
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
|
Aim of study: To prospectively study the effects of intraoperative phlebotomy on blood transfusion requirements during living donor liver transplantation in a randomised controlled trial. Background/Origin of the proposal: Intraoperative blood loss during living donor liver transplantation (LDLT) contributes significantly to morbidity, transfusion-related complications, and graft dysfunction. One strategy used to reduce venous bleeding is controlled phlebotomy, which aims to reduce central venous pressure particularly during the pre-anhepatic phase. Rationale of the study supported by cited literature for the hypothesis and primary objective – Portal hypertension contributes significantly to the blood loss during liver transplant surgery. Controlled phlebotomy helps to reduce portal hypertension in the dissection phase and thereby helps in reducing blood loss. Primary objective of our study is to assess intra-operative red cell requirement in patients undergoing controlled phlebotomy. |