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The effect of local fibrinogen administration on postoperative bleeding in CABG patients

The effect of local fibrinogen administration on postoperative bleeding in CABG patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201510222804N9
Enrollment
50
Registered
2015-12-08
Start date
2015-09-30
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

coronary artery bypass graft. Atherosclerotic heart disease

Interventions

Intervention 1: After weaning from cardiopulmonary bypass and infusion of protamine, “fibrinogen” solution including 1 g of fibrinogen in 50 mL volume is flushed over the heart Afterwards, sternum is
whether fibrinogen or placebo. Intervention 2: In the control (placebo) group, after weaning from bypass circuit and protamine infusion, 50 mL of distilled water is flushed over the heart, exactly the
whether fibrinogen or placebo.
Treatment - Drugs
Placebo
In the control (placebo) group, after weaning from bypass circuit and protamine infusion, 50 mL of distilled water is flushed over the heart, exactly the same method as fibrinogen. Finally afterward
After weaning from cardiopulmonary bypass and infusion of protamine, “fibrinogen” solution including 1 g of fibrinogen in 50 mL volume is flushed over the heart Afterwards, sternum is closed and wir

Sponsors

Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 40-75 years old; elective CABG with CPB; constant surgeon; informed written consent. The following conditions were considered as exclusion criteria: emergent or urgent surgery; age more than 75 years or less than 40 years old; diabetes mellitus (or any of its complications like diabetic ketoacidosis or non-ketonic hyperosmolar diabetic coma); any previous history of stroke or underlying cerebral vascular disease; history of deep vein thrombosis; history of underlying hematologic disorders; any carotid plaque creating significant stenosis (stenosis > 75%); underlying pulmonary disorders affecting the spirometry indices significantly (>50% decrease); acute renal failure; chronic kidney disease causing serum Cr>2mg/dL; hepatic failure causing liver function test failure (> 3 times than normal); off pump CABG; any unwanted complication in the operation period; re-starting CPB after weaning from bypass; pulmonary artery pressure >30 before operation; ejection fraction<30%; congestive heart failure.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Hematocrit level. Timepoint: Early 24 hours hematocrit in postoperative period. Method of measurement: Preoperative and postoperative hematocrit level.

Primary

MeasureTime frame
Postoperative bleeding. Timepoint: Early 24 hours in postoperative period. Method of measurement: Postoperative amount of blood loss in chest tube bottles.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Dabbagh

Anesthesiology Research Center

alidabbagh@yahoo.com; alidabbagh@sbmu.ac.ir+98 21 2243 2572

Outcome results

None listed

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