comparision of different protamine to heparin dosing strategies in cardiac surgeries requiring cardio pulmonary bypass

comparision of 1:1 and 0.75:1 protamine to heparin for reversal of heparin in cardiac surgeries requiring cardio-pulmonary bypass: a randomised controlled study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031467

Enrollment

Registered

2021-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: I20-I25- Ischemic heart diseases

Interventions

Intervention1: protamine to heparin dose 0.75:1: the dose of protamine used for reversal of heparin is 0.75mg for every 1 mg of initial heparin dose, intravenous , STAT. Control Intervention1: protam

Eligibility

Inclusion criteria

Inclusion criteria: patients undergoing cardiac surgery requiring cardiopulmonary bypass

Exclusion criteria

Exclusion criteria: known defects of haemostatic system thrombocytopenia surgeries requiring dhca patients who didnt stop clopidogrel 5 days prior to surgery

Design outcomes

Primary

Measure	Time frame
to compare ACT after 0.75:1 protamine to heparin ratio with 1:1 protamine to heparin ratioTimepoint: 1.BASELINE ACT at the start of surgery 2.ACT after giving heparin 4mg/kg 3.ACT immediately after reversal from protamine 4.ACT after 30 min after reversal from protamine	—

Secondary

Measure	Time frame
1.To study protamine adverse reactions. 2.To compare peri-operative blood loss and utilization of blood products in both groups. 3.To study effect of temperature on dose requirements of protamine. Timepoint: 1.Bleed from mediastinal drains will be quantified for 3 hours. 2.Haemoglobin levels will be monitored for 3 hours. 3.Coagulation profile after 4 hours of surgery. 5. Transfusion requirements in first 48 hours after surgery	—

Measure

Time frame

1.To study protamine adverse reactions. 2.To compare peri-operative blood loss and utilization of blood products in both groups. 3.To study effect of temperature on dose requirements of protamine. Timepoint: 1.Bleed from mediastinal drains will be quantified for 3 hours. 2.Haemoglobin levels will be monitored for 3 hours. 3.Coagulation profile after 4 hours of surgery. 5. Transfusion requirements in first 48 hours after surgery

—

Countries

India

Contacts

Public ContactSai Priyanka Balabhadra

nizams institute of medical sciences

saipriyankab@gmail.com9666851195

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026