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The Evaluation of the impact of reduction in the Protamine dose in comparison to its total dose after coronary artery bypass grafting

Evaluation and comparison of bleeding and Activated Clotting Time (ACT) after coronary artery bypass grafting in protamine-heparin injection 1: 1 and protamine-heparin 0.5: 1

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220610055128N1
Enrollment
60
Registered
2023-03-02
Start date
2023-03-10
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Patients in need of coronary artery bypass grafting.

Interventions

Intervention 1: Intervention group: This group involve 30 person that intervention means reduction Protamine dose to the half the usual amount in they is done. In this group relative to the amount rec

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Omitting anti-coagulation drugs at least one week prior to surgery Patient should be a candidate for coronary artery bypass grafting Informed consent to participate in the study CPB duration less than 100 minutes

Exclusion criteria

Exclusion criteria: Allergy and the risk of anaphylaxia shock Coagulation abnormality Bleeding and hemostasis dysfunctions due to non-medical causes Patients dependent on dialysis and patients suffering from blood dyscrasia and known platelet dysfunction Pregnancy Heparin re-administration Need for emergency surgery Patients with BMIs higher than 30 Under 28 degrees hypothermia Dissent to participate in the study

Design outcomes

Primary

MeasureTime frame
Percent of participants with number of Activated Clotting Time near normal domain (70-120) second. Timepoint: 5 minutes after the end of protamine injection. Method of measurement: Activated Clotting Time assessment with Coagulometer device according to second.;Percent of abnormal bleeding. Timepoint: Drainage assessment of the drains and chest tubes 12 hours and 36 hours after the end of surgery. Method of measurement: Drainage assessment of the drains and chest tubes according to cubic centimeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Amir MirMohammadSadeghi

Esfahan University of Medical Sciences

am-sadeghi@mui.ac.ir+98 31 3260 0961

Outcome results

None listed

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