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IRCT20140528017891N7 IRCT 2019-11-24 Tranexamic acid effect on blood volume transmission Comparative of effectiveness prehospital received tranexamic acid on transmission blood volume on severe trauma patients 2019-11-16 anticipated 330 Complete https://irct.ir/trial/40384 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For prevention of selection bios in participants into study groups,we use the randomization methods.Ranom Alloction software will be used for randomization process.Participants will be randomized with blocked randomizationmethod(with random blocks) to recieve drug(inervention).The output of allocation will be specified with A and B for being blind to the research team. In this process,allocated participants in accordance with basic blocks are not predictable, Blinding description: We will inform the supervisor after selecting each patient.Blinding process in this study is triple blinded. They are selected on the randomized output and Its adaption to the participant's number.Blinding process in this study is triple blinded.The intervention will be sent in a form that is not known to the patient statistical analysor and evaluator of the outcomes to decrease the rate of information bios in intervention and outcome valiables. 3 Bleeding in trauma. Intervention 1: Intervention group: They will receive tranexamic acid at an initial dose of one gram of 50 milliliter normal saline within 10 minutes (only once), along with other prehospital treatment processes. In addition, the infusion of a maintenance dose of 1 germ per 100 milliliter will continue in the hospital for eight hours (up to 24 hours in three stages). Intervention 2: Control group: In this group placebo will not be used and only the treatment processes required for the patients 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
خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم
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) Iran (Islamic Republic of) Being at the age of 14-50 Having COAST score more than 2 Bring up to hospital by Tehran emergency medical service 14 years 50 years Both Passing 3 hours from trauma Having signs of Disseminated intravascular coagulation, myocardial infarction, pulmonary embolism, Stroke Warning Signs and Symptoms Allergic reaction T14.5 Injury of blood vessel(s) of unspecified body region Treatment - Drugs Treatment - Drugs Intervention group: They will receive tranexamic acid at an initial dose of one gram of 50 milliliter normal saline within 10 minutes (only once), along with other prehospital treatment processes. In addition, the infusion of a maintenance dose of 1 germ per 100 milliliter will continue in the hospital for eight hours (up to 24 hours in three stages). Control group: In this group placebo will not be used and only the treatment processes required for the patients will be performed. Bleeding control. Timepoint: Up to 24 hours after admission to hospital. Method of measurement: Get blood products. Mortality. Timepoint: Up to 24 hours after admission to hospital. Method of measurement: Vital signs observation in patient. Length time in intensive care unit. Timepoint: The number of days the patient is in intensive care. Method of measurement: Counting the days when the patient was in the ward. Tehran Emergency Center Tehran Emergency Center Approved 2019-08-17 Ethics committee of Iran university of Medical Sciences بزرگراه همت، دانشگاه علوم پزشکی ایران Tehran Tehran Iran (Islamic Republic of)