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IRCT20140528017891N6 IRCT 2019-02-24 Iran University of Medical Sciences 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 2019-01-29 anticipated 60 Complete https://irct.ir/trial/36555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Acute haemorrhagic gastritis. 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 acute gastrointestinal bleeding of intravenous pantoprazole and hydration will be performed. Intervention 2: Control group: In this group, 50 milliliters of saline solution will be infused nine percent. Saline solution manufactured by Samen company in Iran. In addition, the standard treatment of acute gastrointestinal bleeding of intravenous pantoprazole and hydration will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Has not been proposed in the research team.
public Nader Tavakoli
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 Tavakoli.n@iums.ac.ir Iran University of Medical Sciences scientific Nader Tavakoli
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 Tavakoli.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Having acute gastrointestinal bleeding At least 18 years old 18 years no limit Both 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 K29.01 Acute gastritis with bleeding Treatment - Drugs Placebo 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 acute gastrointestinal bleeding of intravenous pantoprazole and hydration will be performed. Control group: In this group, 50 milliliters of saline solution will be infused nine percent. Saline solution manufactured by Samen company in Iran. In addition, the standard treatment of acute gastrointestinal bleeding of intravenous pantoprazole and hydration will be performed. 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. 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. Iran University of Medical Sciences Approved 2019-01-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)