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Comparison of two protamine dosing methods for reversal of heparin after heart surgery using cardiopulmonary bypass

Comparison of two doses of protamine for heparin reversal after cardiopulmonary bypass surgeries A double blinded randomised prospective comparative study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110665
Enrollment
60
Registered
2026-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I258- Other forms of chronic ischemic heart disease

Interventions

Intervention1: Protamine: Fixed dose protamine 200mg IV Control Intervention1: Protamine: Conventional protamine dosing : 1mg protamine per 100 units of heparin

Sponsors

SMS MEDICAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Provided with written consent ASA physical status 2 Scheduled for elective open cardiopulmonary bypass surgery Adult weighing 40-70 kgs

Exclusion criteria

Exclusion criteria: Emergency surgery End stage renal disease Known coagulation disorder Inadequate cessation of anticoagulants Patient on anticoagulants Heparin allergy and resistance

Design outcomes

Primary

MeasureTime frame
To assess and compare the total protamine dose required in peri operative periodTimepoint: From administration of heparin till end of surgery—

Secondary

MeasureTime frame
To assess & compare total dose of protamine used in intraoperative periodTimepoint: During intraoperative period till completion of surgery;To assess & compare post comparative outcomes, including 24 hour chest tube output & blood transfusion requirementsTimepoint: During intraoperative period till completion of surgery;To assess & compare the incidence & severity of drug related adverse effectsTimepoint: During intraoperative period till completion of surgery—

Countries

India

Contacts

Public ContactDr Anjum Saiyed

SMS MEDICAL COLLEGE AND HOSPITAL

Maahee202g@gmail.com8078637456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026