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Effect of intravenus fibrinogen on blood transfusion in patients with acute gastrointestinal bleeding

Effect of intravenus fibrinogen versus placebo on blood transfusion requirements in patients with acute gastrointestinal bleeding

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140528017891N6
Enrollment
60
Registered
2019-02-24
Start date
2019-01-29
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Acute haemorrhagic gastritis. Acute gastritis with bleeding

Interventions

Intervention 1: Intervention group: Fibrinogen one gram diluted in 50 milliliters of distilled water. Fibrinogen manufactured by CSL Behring company in USA. In addition, the standard treatment of acut

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having acute gastrointestinal bleeding At least 18 years old

Exclusion criteria

Exclusion criteria: Congenital diseases or acquired coagulation disorder Myocardial infarction two months ago History of gastrointestinal bleeding History of heart disease Fibrinogen sensitivity Pregnancy Cirrhosis Vasculitis The presence of any type of cancer

Design outcomes

Primary

MeasureTime frame
Rebleeding. Timepoint: 24 and 72 hours and 28 days after intervention. Method of measurement: Hemoglobin test.;The need for blood transfusion or its products. Timepoint: 24 and 72 hours and 28 days after intervention. Method of measurement: Hemoglobin test.

Secondary

MeasureTime frame
Mortality. Timepoint: 24 and 72 hours and 28 days after intervention. Method of measurement: Observation and clinical examinations of the patient.;Administration in intensive care unit. Timepoint: 24 and 72 hours and 28 days after intervention. Method of measurement: Administrated patients in the intensive care unit.;Need for endoscopy. Timepoint: 24 and 72 hours and 28 days after intervention. Method of measurement: Endoscopy performed in patients under study.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNader Tavakoli

Iran University of Medical Sciences

Tavakoli.n@iums.ac.ir+98 21 6653 9260

Outcome results

None listed

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