| CTRI Number |
CTRI/2023/07/055633 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Low dose protamine for reversal of heparin anticoagulation in cardiac surgery |
|
Scientific Title of Study
|
Effectiveness of low-dose protamine regimes on reversal of heparin anticoagulation during off pump coronary artery bypass grafting (OPCABG) surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANIVESH JAIN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SUPERSPECIALITY HOSPITAL ,NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8085703987 |
| Fax |
|
| Email |
aniveshjain09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHWANATH MOHIRE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SUPERSPECIALITY HOSPITAL NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8744090856 |
| Fax |
|
| Email |
vbm201a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VISHWANATH MOHIRE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SUPERSPECIALITY HOSPITAL NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8744090856 |
| Fax |
|
| Email |
vbm201a@gmail.com |
|
|
Source of Monetary or Material Support
|
| NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
|
|
Primary Sponsor
|
| Name |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Type of Sponsor |
Government medical college |
|
|
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 Vishwanath Mohire |
Superspeciality Hospital Netaji Subhash Chandra Bose Medical College Jabalpur |
Department Of Anaesthesiology Superspeciality Hospital Netaji Subhash Chandra Bose Medical College Jabalpur
Jabalpur
MADHYA PRADESH |
8744090856
vbm201a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JabalpurM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Protamine |
Protamine dose 1/2 of the total dose of heparin. |
| Intervention |
Protamine |
Protamine dose 2/3rd of the total dose of heparin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
NYHA CLASS I TO III
LVEF > 35%
CORONARY ARTERY BYPASS GRAFT < 5 |
|
| ExclusionCriteria |
| Details |
PREOPERATIVE CONGENITAL/ ACQUIRED DISORDERS OF HAEMOSTASIS
PATIENT NEEDED IABP SUPPORT
ACS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the lowest optimal dose of protamine needed for effective reversal of heparin anticoagulation. |
8 weeks,16weeks,24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of low dose regime of protamine 2/3rd & 1/2 of the total dose of heparin in OPCABG & to ascess the extent of restoration of coagulation after low dose regimes of protamine |
12 months |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/08/2023 |
| 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="0"
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
|
The study titled ’’ Effectiveness of low dose Protamine regimes on reversal of heparin anticoagulation during off pump coronary artery bypass grafting ( OPCABG ). The study will be conducted at Superspeciality Hospital ,NSCB Medical college, Jabalpur. Aim is to determine the lowest optimal dose of protamine needed for effective reversal of Heparin anticoagulation. Objectives is to -compare effectiveness of the low dose regime of protamine 2/3rd and 1/2 of the total dose of heparin in off pump CABG and to ascess the extent of restoration of coagulation after administration of low dose regime of protamine in off pump CABG patient. Total number of patient included in group 1 is 40 and group 2 is 40. Group 1 patient will recieve protamine, 2/3 rd of total dose of heparin.Group patients will recieve protamine, 1/2 of the total dose of heparin. |