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IRCT20220521054939N1 IRCT 2022-12-14 Mazandaran University of Medical Sciences Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study 2022-07-06 anticipated 30 Complete https://irct.ir/trial/63685 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be randomly selected and placed in one of two intervention groups (group A) and placebo (group B) by block randomization method. Random Allocation software version 2 will be used for random arrangement of samples in blocks. In this software, we set the number of groups to 2 (1: group A and 2: group B), and the number of samples to 30 (based on the sample size), the size of the blocks is equal, and the coding is a combination of letters and We put a random number. The statistically significant level will be set at 0.05, Blinding description: In order to hide (blinding) the random allocation, the SNOSE method is used. This method is one of the common methods in hiding random allocation. In this method, first, a random sequence is created using the mentioned software, then based on the sample size, a number of envelopes with aluminum envelopes (in order to make the contents of the envelopes unclear) are prepared and each of the random sequences created ( intervention or control group) is recorded on a card and the cards are placed in the envelopes in order. In order to preserve the random sequence, naming is done on the outer surface of the envelopes in the same order as it was produced by the software (for example: TF8G is written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed in a box. At the time of starting the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. 3 Traumatic brain injury. Intervention 1: Intervention group: Indomethacin in the amount of 25 mg for 5 days will be administered intravenously in an initial loading dose of 0.8 mg/kg in 100 cc of normal saline solution over 10-15 minutes. Then it will continue with a dose of 0.5 mg/kg/h. After 2 hours, in order to prevent the phenomenon of ICP rebound, the indomethacin infusion will be reduced by 20% of the dose every 6 hours. Intervention 2: Control group: Placebo in the amount of 25 mg for 5 days. 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 There is no further information
public Saeed Ehteshami
Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 s.ehteshami@ mazums.ac.ir Mazandaran University of Medical Sciences scientific Saeed Ehteshami
Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 s.ehteshami@ mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Registration of informed consent of the first degree patient to participate in the study Age 16 to 70 years Severe traumatic brain injury with closed or penetrating mechanism High resistant ICP 8 ≤GCS 16 years 70 years Both Pregnancy Brain death Coagulation disorders History of gastrointestinal bleeding or active bleeding History of peptic ulcer Acute kidney injury History of allergies to nonsteroidal anti-inflammatory drugs Clinical signs and symptoms of renal failure or its history Hyperkalemia Liver failure S06.0 Concussion Treatment - Drugs Placebo Intervention group: Indomethacin in the amount of 25 mg for 5 days will be administered intravenously in an initial loading dose of 0.8 mg/kg in 100 cc of normal saline solution over 10-15 minutes. Then it will continue with a dose of 0.5 mg/kg/h. After 2 hours, in order to prevent the phenomenon of ICP rebound, the indomethacin infusion will be reduced by 20% of the dose every 6 hours. Control group: Placebo in the amount of 25 mg for 5 days Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale. Degree of disability or dependence in daily activities. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale. Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2022-07-06 Ethics committee in the research of educational center in Mani Imam Khomeini, Sari Amir Mazandarani Boulevard, Imam Khomeini Hospital Sari Mazandaran Iran (Islamic Republic of)