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IRCT20190717044255N2 IRCT 2020-11-13 Arak University of Medical Sciences Comparison of the effect of vasopressin and tranexamic acid on gastrointestinal bleeding Comparison of the effect of tranexamic acid and vasopressin on the outcome of severe gastrointestinal bleeding in patients referred to the emergency department 2020-11-21 anticipated 120 Complete https://irct.ir/trial/51881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Gastrointestinal bleeding. Intervention 1: Control group: 30 patients will be treated with standard gastrointestinal bleeding treatment and the first placebo of normal saline will be infused 100 cc in 20 minutes and then 100 cc per hour for up to 4 hours. The second normal saline placebo will be injected at 100 cc per hour for up to 6 hours. Treatment with both types of placebo will be performed for patients from the time of admission. Intervention 2: Intervention group: Intervention group 1: 30 patients will be treated with standard gastrointestinal bleeding treatment and tranexamic acid drug from the beginning of hospitalization (Caspian drug, Iran) will first be infused at a dose of 10 mg / kg in the initial dose for 20 minutes and then 1mg / kg per hour as a maintenance dose for up to 4 hours for the patient. Normal saline placebo is also injected simultaneously and 100 cc per hour for 6 hours for the patient. Intervention 3: Intervention group 2: 30 patients will be treated with standard gastrointestinal bleeding treatment and vasopressin will be prescribed at the rate of 30 units per hour (at a rate of 0.5 units per minute) for 6 hours from the beginning of hospitalization (drug elixir, Iran). Normal saline placebo is also injected simultaneously and 100 cc infusion in the first 20 minutes and 100 cc per hour for 4 hours for the patient. Intervention 4: Intervention group 3: 30 patients will be treated with standard gastrointestinal bleeding treatment and tranxamic acid drug from the beginning of hospitalization (Caspian drug, Iran) will first be infused at a dose of 10 mg / kg in the initial dose for 20 minutes and then 1mg / kg per hour as a maintenance dose for up to 4 hours is prescribed to the patient. Also, vasopressin is prescribed at the rate of 30 units per hour (at a rate of 0.5 units per minute) for 6 hours from the beginning of hospitalization (Elixir of Medicine, Iran). 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 No more information
public Simin najafgholian
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ 00980863136055 info@arakmu.ac.ir Arak University of Medical Sciences scientific Simin Najafgholian
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 5819396548 0098863136055 info@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients with a diagnosis of severe upper or lower gastrointestinal bleeding no limit no limit Both Previous allergy to vasopressin or tranexamic acid coagulation disorders Suspected acute myocardial infarction K92.2 Gastrointestinal hemorrhage, unspecified Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: 30 patients will be treated with standard gastrointestinal bleeding treatment and the first placebo of normal saline will be infused 100 cc in 20 minutes and then 100 cc per hour for up to 4 hours. The second normal saline placebo will be injected at 100 cc per hour for up to 6 hours. Treatment with both types of placebo will be performed for patients from the time of admission. Intervention group: Intervention group 1: 30 patients will be treated with standard gastrointestinal bleeding treatment and tranexamic acid drug from the beginning of hospitalization (Caspian drug, Iran) will first be infused at a dose of 10 mg / kg in the initial dose for 20 minutes and then 1mg / kg per hour as a maintenance dose for up to 4 hours for the patient. Normal saline placebo is also injected simultaneously and 100 cc per hour for 6 hours for the patient. Intervention group 2: 30 patients will be treated with standard gastrointestinal bleeding treatment and vasopressin will be prescribed at the rate of 30 units per hour (at a rate of 0.5 units per minute) for 6 hours from the beginning of hospitalization (drug elixir, Iran). Normal saline placebo is also injected simultaneously and 100 cc infusion in the first 20 minutes and 100 cc per hour for 4 hours for the patient. Intervention group 3: 30 patients will be treated with standard gastrointestinal bleeding treatment and tranxamic acid drug from the beginning of hospitalization (Caspian drug, Iran) will first be infused at a dose of 10 mg / kg in the initial dose for 20 minutes and then 1mg / kg per hour as a maintenance dose for up to 4 hours is prescribed to the patient. Also, vasopressin is prescribed at the rate of 30 units per hour (at a rate of 0.5 units per minute) for 6 hours from the beginning of hospitalization (Elixir of Medicine, Iran). Gastrointestinal bleeding volume. Timepoint: During the first 24 hours after receiving the drug. Method of measurement: Using a Calibrated container or non-sterile gas (each blood gas completely impregnate with equivalent to 20 ml blood ). Blood pressure. Timepoint: Every 30 minutes to 24 hours after receiving the drug. Method of measurement: Automatic arm pressure gauge cuff. Pulse rate. Timepoint: Every 30 minutes to 24 hours after receiving the drug. Method of measurement: Pulse oximeter device. Patients venous hemoglobin concentration. Timepoint: When patients are admitted to the emergency room and then every 6 hours, up to 24 hours after receiving the drug. Method of measurement: Based on laboratory results by Cell counter device model H1. Arak University of Medical Sciences Approved 2020-02-02 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardasht Arak Markazi Iran (Islamic Republic of)