Effect of fibrinogen compared to fresh frozen plasma on patients with hemorrhagic shock

Comparison of the fibrinogen and fresh frozen plasma efficacy in patients outcome with hemorrhagic shock due to multiple trauma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150704023046N4

Enrollment

Registered

2020-02-08

Start date

2019-03-21

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Condition 1: Hemorrhagic shock. Condition 2: Hypovolemic shock. Hemorrhage, not elsewhere classified Hypovolemic shock

Interventions

Intervention 1: Intervention group: Patients receiving Packed Cell and Frozen Fresh Plasma in proportion (FFP: 1: 1 PRbc Ratio). Intervention is performed for each patient at one time in the emergency

Eligibility

Sex/Gender

All

Age

14 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with hemorrhagic shock caused by multiple trauma Age> 14 years Systolic blood pressure <90 mm Hg Significant chance of bleeding Evidence of intra abdominal bleeding Clinical judgment of the doctor about the receipt of blood products

Exclusion criteria

Exclusion criteria: Pregnancy Patients with known coagulopathy Using anti-coagulant and anti-platelet drugs Other causes of shock, such as neurogenic shock Previous history of blood product in the last 6 months Patients are severely ill, whose priority is to preserve the patient's health Dissatisfaction with the patient or patient companions to participate in the study

Design outcomes

Primary

Measure	Time frame
Blood Pressure. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: Clinical examination and assessment of vital signs by cardiac monitoring and pulse oximetry located in the cardiopulmonary resuscitation room.;Oxygenation index. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: pulse oximetry located in the cardiopulmonary resuscitation room.;PH level. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: By taking arterial blood samples and evaluating arterial blood gas by laboratory tests.;Duration of admission. Timepoint: When ordering a patient's discharge or issuing a death certificate. Method of measurement: Clinical examination and evaluation of patient records.	—

Measure

Time frame

Blood Pressure. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: Clinical examination and assessment of vital signs by cardiac monitoring and pulse oximetry located in the cardiopulmonary resuscitation room.;Oxygenation index. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: pulse oximetry located in the cardiopulmonary resuscitation room.;PH level. Timepoint: 4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day. Method of measurement: By taking arterial blood samples and evaluating arterial blood gas by laboratory tests.;Duration of admission. Timepoint: When ordering a patient's discharge or issuing a death certificate. Method of measurement: Clinical examination and evaluation of patient records.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Karimpour

Ahvaz University of Medical Sciences

Dr.EhsanKarimpour@Gmail.Com+98 61 3222 2818

Outcome results

None listed

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