| CTRI Number |
CTRI/2025/01/079054 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of a diagnostic test technique for deciding the transfusion of blood products in liver disease patients. |
|
Scientific Title of Study
|
Comparison of Blood Products Required Using Two Different ROTEM Cut-offs Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure (ACLF) Patients With Severe Coagulopathy: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanda Kavitha |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
sandakavitha1001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar Sharma |
| Designation |
Professor & Head, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
manojkumardm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Kumar Sharma |
| Designation |
Professor & Head, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
manojkumardm@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj,new Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj,New Delhi-110070. |
| 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 Sanda Kavitha |
Institute of Liver and Biliary Sciences |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
sandakavitha1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Cut Off ROTEM Tests |
EXTEM CT m0re than 100sec, CL130 less than 40% FIBTEM- Mcf less than 6 |
| Comparator Agent |
Low Cut Off ROTEM Tests |
EXTEM CT more than 80sec, CL130 less than 50% FIBTEM- Mcf more than 8 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Cirrhosis and ACLF ( as per definition)
2. Planned to undergo invasive procedures
3. Severe Coagulopathy- INR more than 2.0 or Platelets less than 30k or Fibrinogen less than 100mg per dl |
|
| ExclusionCriteria |
| Details |
1. Ongoing bleeding
2. Bleeding in past 48 hours before procedure
3. Antiplatelet or anticoagulant therapy ( stopped less than 7 days before) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the effectiveness of High cutoff vs Low cut off ROTEM in guiding blood products use before invasive procedures in cirrhosis and ACLF patients
|
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the impact of ROTEM on transfusion requirements |
28 days |
| Evaluate the incidence of bleeding events post procedure in Low cutoff |
28 days |
| Evaluate the mortality in patients with procedural bleeding. |
28 days |
| Assess the patient requiring procedural based treatment after post procedural bleed. |
28 days |
| To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="934"
Sample Size from India="934"
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)
|
31/01/2025 |
| 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) |
Open to Recruitment |
|
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 and Objective - To evaluate the efficacy and safety of
relaxed threshold (compared to threshold) for blood product transfusion for
invasive procedures in cirrhosis and ACLF patients.
Hypothesis - Relaxing the threshold ( as compared to
conventional threshold ) for blood product transfusion will decrease the need
for blood products without increase the bleeding complications for invasive
procedures in cirrhosis and acute on chronic liver failure patients( ACLF)
Sample size with justification:
Assuming the prevalence rate is 50% (TUSHAR THESIS -yet to
be published), that is need of transfusion of blood produtcs in standard cutoff
and relaxed cutoff , as according to this study the need in relaxed cut off has
been reduced,we assumed the need in High cut off group is reduced to 40%, with
alpha-5%, power-80%, we need to enroll 417 in each group with defaulter of 10%
, it decided to have cases that is 934 total Monitoring and assessment: All
patients would undergo vital and baseline parameter screening before
randomization. Based on randomization we will assess the need for transfusion ,
and complications post procedure , post transfusion if any for a duration of
1month.
Intervention: Patient after screening for all
exclusion criteria will be randomized to procedure after or before transfusion
of blood products and will be assessed the safety of procedure related bleed
and need of intervention post procedure if any |