Effect of fibrinogen on bleeding after cardiac surgery

Studying effect of tranexamic acid plus fibrinogen on mediastinal bleeding in cardiac patients after open heart surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013082714489N1

Enrollment

Registered

2014-04-07

Start date

2013-11-22

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

Condition 1: Ischemic heart diseases. Condition 2: Nonrheumatic mitral valve disorders. Condition 3: Nonrheumatic aortic valve disorders. Condition 4: Nonrheumatic tricuspid valve disorders. Condition 5: Pulmonary valve disorders. Condition 6: Rheumatic heart diseases. Angina pectoris, unspecified Nonrheumatic mitral valve disorders, unspecified Nonrheumatic aortic valve disorders, unspecified Nonrheumatic tricuspid valve disorders, unspecified Pulmonary valve disorders, unspecified Acute

Interventions

Intervention 1: The subjects in the intervention group are injected with 15mg/kg tranexamic acid plus 2 g(grams) fibrinogen (Haemocomplettan as the generic name). Afterwards, the length of stay in the

Treatment - Drugs

The subjects in the intervention group are injected with 15mg/kg tranexamic acid plus 2 g(grams) fibrinogen (Haemocomplettan as the generic name). Afterwards, the length of stay in the ICU, mediastina

The second group consists of control subjects who receive 15 mg/kg tranexamic acid and routine care (including blood pressure control and use of blood products according to the paraclinical findings).

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Mediastinal drainage of more than 200 cc/hour after cardiac surgery, 2) Age30% and 4) Body Mass Index (BMI)<30; Exclusion criteria: 1) Emergency or second cardiac surgery, 2) Hemoglobin (Hb)<10, 3) platelet count<100,000/cc, and 4) Hematologic diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Mediastinal bleeding. Timepoint: Conducted on an hourly basis for 48 hours from the time of ICU admission after surgery (before and after the intervention). Method of measurement: Registered in the questionnaire (cc/hour).	—

Secondary

Measure	Time frame
Mortality. Timepoint: Measured daily during the hospital stay before and after the intervention. Method of measurement: Registered in the questionnaire according to patients percentage until discharge.;ICU length of stay. Timepoint: The length of post-operative ICU stay before and after the intervention. Method of measurement: Registered in the questionnaire on a daily basis.;Blood product usage (fresh frozen plasma, platelets, packed cells, whole blood). Timepoint: Registered every 4 hours for a 48 hours period, during the post-operative ICU stay (before and after the intervention). Method of measurement: Registered in the questionnaire according to the products bag.	—

Measure

Time frame

Mortality. Timepoint: Measured daily during the hospital stay before and after the intervention. Method of measurement: Registered in the questionnaire according to patients percentage until discharge.;ICU length of stay. Timepoint: The length of post-operative ICU stay before and after the intervention. Method of measurement: Registered in the questionnaire on a daily basis.;Blood product usage (fresh frozen plasma, platelets, packed cells, whole blood). Timepoint: Registered every 4 hours for a 48 hours period, during the post-operative ICU stay (before and after the intervention). Method of measurement: Registered in the questionnaire according to the products bag.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Mohammad Esmaeelzadeh

Mashhad university of medical sciences

Esmaeilzm901@mums.ac.ir+98 51 1802 2314

Outcome results

None listed

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