Prophylactic concentrate fibrinogen in coronary artery bypass surgery

The effect of prophylactic use of fibrinogen concentrate on postoperative blood fibrinogen levels, amount of bleeding, and need for transfusion in patients with normal blood fibrinogen levels undergoing coronary artery bypass graft surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180724040575N8

Enrollment

Registered

2025-09-02

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Patients undergoing coronary bypass surgery.

Interventions

Intervention 1: Intervention group: Injection of fibrinogen concentrate at a dose of 2 grams within 15 minutes after turning off the cardiopulmonary pump and injection of protamine. Intervention 2: Co

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for coronary bypass surgery Age 40 to 80 years Normal blood fibrinogen level (200 to 400 mg/dL)

Exclusion criteria

Exclusion criteria: Known sensitivity to fibrinogen concentrate Patient dissatisfaction Renal failure Hepatic failure Coagulation disorder Off Pump surgery Emergency surgery

Design outcomes

Primary

Measure	Time frame
Blood fibrinogen level. Timepoint: Before the start of the operation and 24 hours after the end of the operation. Method of measurement: Blood sampling and measurement of blood fibrinogen levels based on milligrams per deciliter.;Patient's hemoglobin. Timepoint: Before, during and after surgery up to 24 hours after surgery along with each blood gas sampling. Method of measurement: Arterial blood sampling and hemoglobin measurement based on grams per deciliter.;Number of blood products transfusions needed for the patient during and after surgery for up to 24 hours. Timepoint: At the end of 24 hours based on the patient's record. Method of measurement: Number based on patient record.;Patient drainage from the end of the operation until 24 hours after the surgery. Timepoint: At the end of 24 hours after surgery. Method of measurement: Considering the patient's record and based on the milliliters of blood excreted in the drain bottle.	—

Measure

Time frame

Blood fibrinogen level. Timepoint: Before the start of the operation and 24 hours after the end of the operation. Method of measurement: Blood sampling and measurement of blood fibrinogen levels based on milligrams per deciliter.;Patient's hemoglobin. Timepoint: Before, during and after surgery up to 24 hours after surgery along with each blood gas sampling. Method of measurement: Arterial blood sampling and hemoglobin measurement based on grams per deciliter.;Number of blood products transfusions needed for the patient during and after surgery for up to 24 hours. Timepoint: At the end of 24 hours based on the patient's record. Method of measurement: Number based on patient record.;Patient drainage from the end of the operation until 24 hours after the surgery. Timepoint: At the end of 24 hours after surgery. Method of measurement: Considering the patient's record and based on the milliliters of blood excreted in the drain bottle.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamal Fani

Shahid Beheshti University of Medical Sciences

kamalfani@sbmu.ac.ir+98 21 2207 4095

Outcome results

None listed

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