Efficacy of the fibrinogen and Fresh frozen plasma in patients with severe trauma

Survey Efficacy of the fibrinogen and Fresh frozen plasma in the hemodynamic and clinical outcomes of patients with severe trauma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017051923559N13

Enrollment

Registered

2017-11-05

Start date

2018-03-21

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

Trauma. Other early complications of trauma

Interventions

Intervention 1: first group will be treated with fibrinogen extract (made in Iranian Blood Transfusion Organization, 70 mg/kg, every 8 hours until the INR reaches under 1.8 ). Intervention 2: second

Treatment - Drugs

first group will be treated with fibrinogen extract (made in Iranian Blood Transfusion Organization, 70 mg/kg, every 8 hours until the INR reaches under 1.8 )

second group will be treated with FFP (made in Iranian Blood Transfusion Organization, 10- 15 mg/kg, every 8 hours until the INR reaches under 1.8)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age over 18 years old; patients with multiple trauma; need for repeated transfusion; injury severity score 16 and above; satisfaction to participate in the study. Exclusion criteria: Unwillingness of the patient to continue cooperation in the plan; trauma limited to head; Penetrating trauma; injury severity score less than 16.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: 4 and 12 hours after the beginning of the intervention. Method of measurement: Manual blood pressure monitor.;Blood PH. Timepoint: 4 and 12 hours after the beginning of the intervention. Method of measurement: Lab.;Oxygenation index. Timepoint: 4 and 12 hours after the beginning of the intervention. Method of measurement: Lab.	—

Secondary

Measure	Time frame
Types of brain and organ damage. Timepoint: At the beginning of the intervention. Method of measurement: Imaging through CT scan.;Level of consciousness. Timepoint: At the beginning of the intervention. Method of measurement: Using the Glasgow Coma Score.;Days requiring mechanical ventilation. Timepoint: During hospital admission. Method of measurement: Counting the days required for mechanical ventilation.;Number of blood units taken. Timepoint: During the days of admission. Method of measurement: Count of injected blood units.;Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Count the number of admitted days.;Patients death. Timepoint: End of intervention. Method of measurement: Clinical.	—

Measure

Time frame

Types of brain and organ damage. Timepoint: At the beginning of the intervention. Method of measurement: Imaging through CT scan.;Level of consciousness. Timepoint: At the beginning of the intervention. Method of measurement: Using the Glasgow Coma Score.;Days requiring mechanical ventilation. Timepoint: During hospital admission. Method of measurement: Counting the days required for mechanical ventilation.;Number of blood units taken. Timepoint: During the days of admission. Method of measurement: Count of injected blood units.;Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Count the number of admitted days.;Patients death. Timepoint: End of intervention. Method of measurement: Clinical.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ehsan Akbari

Shahid Beheshti University of Medical Sciences

akbari.ehsandr@gmail.com+98 21 2240 3821

Outcome results

None listed

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