| CTRI Number |
CTRI/2023/12/060804 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood products used in cirrhosis with Non-variceal Bleeding |
|
Scientific Title of Study
|
Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding: 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 Saurav Paul |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
saurav.paul79@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, Institute of Liver and Biliary Sciences, 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, Institute of Liver and Biliary Sciences, 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 |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, 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 Saurav Paul |
Institute of Liver and Biliary Sciences |
Room No. 3330, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
saurav.paul79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Liver and Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ROTEM Group |
In ROTEM group if CT EXTEM 80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM 35 and MCF FIBTEM 8 CRYO or Fibrinogen concentrate, if MCF EXTEM35 and MCF FIBTEM 8 Platelet, CL LY50 Trenaxemic acid.
Duration: Till the bleeding episodes stops |
| Comparator Agent |
THROMBOELASTOGRAPHY |
Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°
Duration: Till the bleeding episodes stops |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Cirrhosis of any etiology
2. Age between 18 and 80 years;
3. Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing
4. bleed form a nonvariceal source); and
5. Significant coagulopathy assessed by CCTs (INR > 1.8 and/or PLTs < 50 × 109/L).
|
|
| ExclusionCriteria |
| Details |
1. Variceal bleed
2. Post Variceal ligation ulcer bleed
3. Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel;
4. Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study;
5. Pregnancy
6. Significant cardiopulmonary diseases.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative volume of FFP transfused at Day 5. |
Day 5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cumulative volume of Cryoprecipitate, Platelet and Trenaxemic acid
Transfusion related reactions
|
Week 6 |
Duration of intensive care unit (ICU) and hospital stay; and
Survival at 6 weeks
|
Week 6 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/01/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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:- To compare Rotational thrombo- elastometry vs Thrombo- elastography as a guide for blood component transfusion in patients of Cirrhosis with nonvariceal bleeding.
Methodology:- After fulfilling all inclusion and exclusion criteria, patients were randomized to either the TEG or ROTEM group in a 1:1 proportion. Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.In ROTEM group if CT EXTEM >80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM <35 and MCF FIBTEM <8 CRYO or Fibrinogen concentrate, if MCF EXTEM<35 and MCF FIBTEM >8 Platelet, CL LY>50 Trenaxemic acid
Study population: patients with Cirrhosis of liver with nonvariceal bleeding Study design: Randomized controlled trial Study period: 1 years after ethical clearance
Sample size: Assuming that total volume of FFP used in TEG 760 ± 370 and further in ROTEM volume used 510±275 with α 5% power 90, we need to enrol 72 cases. Further assuming 10% inadequacy We had decided to enroll a total of 80 patients, 40 in each group.The allocation will be done randomly by block randomization method.
Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.
STATISTICAL ANALYSIS: The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value<0.05 will be considered as significant.
Adverse effects:Transfusion related complication
Stopping rule: If patient decided to withdraw from study
|