Low dose protamine for reversal of heparin anticoagulation in cardiac surgery

Not Applicable

Not yet recruiting

• Conditions: Atherosclerotic heart disease of native coronary artery,

• Registration Number: CTRI/2023/07/055633
• Lead Sponsor: NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-24
• Study Start: 2023-08-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

NYHA CLASS I TO III LVEF > 35% CORONARY ARTERY BYPASS GRAFT < 5.

Exclusion Criteria

PREOPERATIVE CONGENITAL/ ACQUIRED DISORDERS OF HAEMOSTASIS PATIENT NEEDED IABP SUPPORT ACS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the lowest optimal dose of protamine needed for effective reversal of heparin anticoagulation.	8 weeks,16weeks,24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Superspeciality Hospital Netaji Subhash Chandra Bose Medical College Jabalpur; 🇮🇳 Jabalpur, MADHYA PRADESH, India

Superspeciality Hospital Netaji Subhash Chandra Bose Medical College Jabalpur

🇮🇳Jabalpur, MADHYA PRADESH, India

Dr Vishwanath Mohire

Principal investigator

8744090856

vbm201a@gmail.com