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Effect of prophylactic fibrinogen on post operative bleeding in coronary artery bypass graft surgery

Effect of Prophylactic Fibrinogen Concentrate Infusion on Postoperative Bleeding in Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blinded Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201011085140N1
Enrollment
60
Registered
2011-06-07
Start date
2009-01-25
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Hemorrhage. Hemorrhage, not elsewhere classified

Interventions

Intervention 1: control group: the patients were administered 1 gr of placebo dissolved in 50 millimeters of normal saline over a 15 minute period after induction of anesthesia before the start of sur
Placebo
Treatment - Drugs
control group: the patients were administered 1 gr of placebo dissolved in 50 millimeters of normal saline over a 15 minute period after induction of anesthesia before the start of surgery.
Interventional group: In the fibrinogen group the patients were administered 1 gr of fibrinogen dissolved in 50 millimeters of normal saline over a 15 minute period after induction of anesthesia befor

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All candidates for first time elective coronary artery bypass graft surgery. Exclusion criteria: 1-Previously diagnosed hematologic or liver disease, 2-uncontrolled or insulin dependent diabetic mellitus, 3-pregnancy, 4-unstable angina, 5-serum creatinine > 130 µmol/L, 6-left ventricular ejection fraction of less than 35% prior to surgery, 7-serum fibrinogen levels of more than 3/5 g/L.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Volume of postoperative hemorrhage. Timepoint: 0,12,24h after surgery. Method of measurement: overall chest tube drainage during the first 24 hour postoperative hours and was recorded by a pre-trained intensive care unit nurse.

Secondary

MeasureTime frame
Transfusion of blood products. Timepoint: first 24 hours post surgery. Method of measurement: The amount of transfused red pack cells, fresh frozen plasma, and platelets during the first 24 hour post-surgery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Movafegh

Anesthesiology Dep, Tehran University of Medical Sciences

movafegh@sina.tums.ac.ir , ali@movafegh.com+98 21 8490 2372

Outcome results

None listed

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