Appropriate protamine dosage for post cardiopulmonary bypass patient with borderline activated clotting time

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190308003

Enrollment

140

Registered

2019-03-08

Start date

2019-03-08

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

elective cardiac surgery patients using cardiopulmonary bypass age between 18&#45

Interventions

Protamine drug dose 0.5 mg/kg as second dose for patient with borderline ACT (ACT 120&#45

160 sec) after routine heparin reversal,no drug

Active Comparator Drug,Placebo Comparator Drug

protamine 0.5 mg/kg,no drug

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.elective cardiac surgery patients using cardiopulmonary bypass 2.no bleeding tendency preoperative (abnormal platelet, aPTT, PT, INR) 3. no preoperative anticoagulant drugs

Exclusion criteria

Exclusion criteria: 1.Suspected heparin resistance, heparin induced thrombocytopenia 2.Hypothermia patient (Core temperature below 36 Celcius) 3.Cardiopulmonary bypass time more than 2 hours activated clotting time (ACT) value after 1st routine protamine dose below 120 seconds or more than 160 seconds or more than baseline value 15% 4.Deny or request for exclude from study

Design outcomes

Primary

Measure	Time frame
post operative bleeding 6 hours after operative drain volume	—

Secondary

Measure	Time frame
laboratory investigation outcome after protamine second dose ACT, activated partial thromboplastin time	—

Countries

Thailand

Contacts

Public ContactNaruemol Prachanpanich

Department of Anesthesiology, Faculty of medicine, Ramathibodi hospital, Mahidol university

Nolruema@hotmail.com66 81 7551137

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026