Comparison of the effect of tranexamic acid and vasopressin on the outcome of severe gastrointestinal bleeding in patients referred to the emergency department

Comparison of the effect of vasopressin and tranexamic acid in controlling severe gastrointestinal bleeding and improving the outcome of patients referred to the emergency department

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 in120 patients. Random blocking method was used for randomization.

This study is a randomized clinical trial study that is performed as a double blind on patients with a diagnosis of severe gastrointestinal bleeding, referred to the emergency room of Amir Al-Momenin and Valiasr hospitals in Arak. clinicians and data analyzers are blind. 120 patients are studied who are randomly divided into four groups. For all 4 groups, the patient is examined at the beginning of admission and the amount of bleeding and then the initial tests including: CBC DIFF, BUN, CR, NA, K, BS, PT, PTT, INR, are checked. Vital signs and blood transfusion rate are performed every half hour and tests are performed every 6 hours for 24 hours (4 times) CBC, BUN, CR re-check. To check the amount of bleeding, a graduated container or non-sterile gas is provided to the patient. The clinical condition of patients in all 4 groups is evaluated and recorded within 24 hours

Inclusion criteria: All patients with a diagnosis of severe upper and lower gastrointestinal bleeding referred to the emergency department. exclusion criteria: vasopressin and tranexamic acid sensitivity, coagulation disorders, suspected acute myocardial infarction

The first group: receiving intravenous tranexamic acid + common standard treatment Group 2: receiving intravenous vasopressin + common standard treatment Group 3: common standard treatment Group 4: receiving both drugs + common standard treatment

Bleeding volume, blood pressure, heart rate, hemoglobin

A total of 120 patients will be divided into four groups of 30 through random blocking with a size of 4 blocks. In this way, by online software (sealedenvelope.com) 30 random sequences of 4 of the names of the studied groups are generated and according to the obtained sequences, the patients will be assigned to different groups, respectively. Assigning individuals to groups using random blocking method will lead to allocation Concealment. In this way, first a random sequence is created by one of the mentioned methods, then based on the sample size of the research, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) are prepared and each of the random sequences is created. It is registered on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

This study is double-blind. In this study, patients will not be aware of the type of drug used and for this purpose, placebo will be used in the control group and only the main executor of the project is aware of the study groups and their drugs. The clinical caregiver and data analyzer are also unaware of the study groups and recognize them only by the letters A, B, C, and D.