FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/10/004072 [Registered on: 17/10/2013] Trial Registered Retrospectively
Last Modified On: 07/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Better Outcomes in Living donor liver transplantation with Terlipressin  
Scientific Title of Study   Double-blind Randomized controlled trial of the peri-operative use of terlipressin in adult living donor liver transplantation. 
Trial Acronym  BOLT (Better Outcomes with Terlipressin in Living donor liver transplantation) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mettu Srinivas Reddy 
Designation  Senior Consultant Surgeon 
Affiliation  Global Hospital and Health City 
Address  Institute of Liver Diseases and Transplantation Global Hospital and Health City Perumbakkam, Chennai, India

Chennai
TAMIL NADU
600100
India 
Phone  9840054648  
Fax    
Email  smettu.reddy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mettu Srinivas Reddy 
Designation  Senior Consultant Surgeon 
Affiliation  Global Hospital and Health City 
Address  Institute of Liver Diseases and Transplantation Global Hospital and Health City Perumbakkam, Chennai, India

Kancheepuram
TAMIL NADU
600100
India 
Phone  9840054648  
Fax    
Email  smettu.reddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mettu Srinivas Reddy 
Designation  Senior Consultant Surgeon 
Affiliation  Global Hospital and Health City 
Address  Institute of Liver Diseases and Transplantation Global Hospital and Health City Perumbakkam, Chennai, India

Kancheepuram
TAMIL NADU
600100
India 
Phone  9840054648  
Fax    
Email  smettu.reddy@gmail.com  
 
Source of Monetary or Material Support  
Global Hospital and Health City, Chennai, India 
 
Primary Sponsor  
Name  Global Hospital health City 
Address  Perumbakkam Chennai 600100 INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Srinivas Reddy  Global Hospital and Health City  Institute of Liver Surgery & Transplantation Global Hospital and Health City Perumbakkam Chennai INDIA 600100
Chennai
TAMIL NADU 
9840054648

smettu.reddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Global Hospital, Chennai, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult End stage liver disease patients undergoing living donor liver transplantation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal saline  Infusion rate calculated by recipient weight in kg divided by 10 rounded off to the nearest ml/hour 
Intervention  Terlipressin  Terlipressin infusion started during living donor liver transplantation and continued for 72 hours postoperatively. Initial bolus of 1mg over 30 minutes followed by 2microgram per kg per hour. Solution prepared by diluting 1mg Terlipressin (Ferring Inc) in 50 ml saline.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients undergoing first living donor liver transplantation for primary liver disease
GRWR<1.2
 
 
ExclusionCriteria 
Details  Combined liver-kidney transplants
Significant pre-operative renal dysfunction (eGFR<50)
Significant uncorrected coronary artery disease
Urgent transplants
Re-transplants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Portal pressure  Before recipient hepatectomy
After arterial reperfusion 
 
Secondary Outcome  
Outcome  TimePoints 
Blood loss
Blood product requirement
Intraoperative urine output
Intraoperative lactate
Intraoperative inotropic requirement
Postoperative renal dysfunction
Postoperative complications
ICU stay
Hospital stay
Adverse effects of trial medication 
Intraoperative
Postoperative 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   05/07/2012 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Cirrhosis is associated with portal hypertension. Shift of blood to the splanchnic circulation with relative decrease of the systemic circulation volume is also well described. This manifests as increased bleeding secondary to portal hypertension during liver transplantation. Peri-operative renal dysfunction is also well described. Living donor liver transplantation involves transplanting a graft liver, which is half the normal liver size into the recipient. This exposes the graft to high portal blood flow termed ‘portal hyperperfusion’. While it resolves spontaneously in mild cases, it has the potential to cause prolonged graft dysfunction when the graft recipient weight ratio (GRWR) is less than 0.8. This is termed ‘small for size syndrome’.

Terlipressin is a vasopressin analogue, which causes splanchnic vasoconstriction leading to a shift of blood from portal to systemic circulation. It is routinely used in management of variceal bleeding and hepato-renal syndrome in cirrhotic patients. Terlipressin can potentially improve outcome in LDLT by decreasing intra-operative haemorrhage, improving renal function and decreasing portal hyperperfusion. It has been reported to improve outcomes in LDLT in a few recent studies. However this area needs further investigation.

The present study is planned as a double blind, randomised controlled trial comparing the use of terlipressin during the peri-transplant period with a placebo group. This study will enroll adults patients undergoing LDLT in our unit with GRWR lesser than 1.2. Subjects will be randomised to terlipressin group or placebo group. Terlipressin group will receive an initial bolus of terlipressin at start of transplant operation followed by continuous infusion for 72 hours post-operatively. Placebo group will receive saline infusion at the same rate loaded in similar looking syringes. The patient and the treating clinicians will be unaware of each patient’s allocation. The primary end-point is a drop in portal pressure after implantation. Secondary end-points of the trial include intra-operative haemo-dynamic parameters, intra-operative blood loss, transfusion requirements, post-operative liver function tests, renal function and morbidity. In addition, histological markers of tissue injury will be compared between the two groups. If significant improvement in post-transplant outcomes can be achieved by the use of peri-operative terlipressin, the latter can become the standard of care for all adult LDLT. 

 
Close