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

The aim of study was to evaluate the effect of fibrinogen administration in patients with acute gastrointestinal bleeding, which will examine the effect of fibrinogen on the rate of rebleeding, mortality and need for blood or its products among participants in the study.

The design of the study is a parallel randomized control trials. Sample size is 60 patients which will be assigned to intervention and control groups using the blocked randomization method.

This study will be carried out at Rasoul Akram hospital that depending on Iran University of Medical Sciences to reduce blood transfusion and risk of rebleeding in patients with acute gastrointestinal bleeding that received fibrinogen. The effect of fibrinogen will be measured on the rate of rebleeding, mortality, and the need to transfer blood or any product at 24, 72 hours, and 28 days after the interventions. Participants in the study and physicians assessing the outcomes on the patients will be blinded the type of interventions that patients will be receive.

Having acute gastrointestinal bleeding and over 18 years of age are inclusion criteria for study. Exclusion criteria are congenital or acquired congenital anomalies; myocardial infarction two months ago; history of gastrointestinal bleeding and sensitivity to fibrinogen.

The intervention group will be consisting of one gram of fibrinogen in 50 milliliters distilled water. Fibrinogen manufactured by CSL Behring pharmaceutical company in United Stated plus a standard pharmaceutical regimen. In the control group, 9% saline solution Samen Pharmaceutical company in Iran will be administered in 50 milliliters with a standard pharmaceutical regimen.

Rebleeding, the need for blood transfusion or its products

To prevent the occurrence of bias in selecting participants for study groups, we will use the randomization method until the researchers' opinion is reduced in selecting participants for the study groups. Participants after selecting to study with blocked randomization method (with random blocks) will be allocated to receive intervention and placebo. The Random Allocation Software will be use to a randomization process since this study consists of two groups, the output of the allocation of participants will be specified with the A and B until intervention to be blinded for the members of the research team. In the software, randomization type will be selected of block randomization, with random blocks. Software output of the allocation participants is not predictable on the basis of blocks.

We will inform the supervisor after selecting each patient for the study and they are based on the randomized output of the randomization software and its matching to the patient's number the intervention will be sent in a form that is not known to the patients, prescriptive, and evaluator of the outcomes. For this, the shape and color of the interventions will be the same. Blinding process in this study is double blinded. Participants in the study will be blinded of interventions also the physicians will be blinded of the type of interventions received by the participants when they evaluated the outcome.

Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Availability eight months after the end of study

Emergency Medicine and Gastroenterologists specialists

In the case of comparison with other similar trials or treatment

Iran University of Medical Sciences

By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results.