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IRCT20210506051200N2 IRCT 2023-04-05 Shahid Beheshti University of Medical Sciences Comparing the effects of mannitol and hypertonic saline on blood coagulation in brain tumor patients Investigating the effects of the simultaneous use of Voluven (hydroxyethyl starch 0.4.130) plus 20% mannitol compared to Voluven plus 3% hypertonic saline on blood coagulation using PFA-100 in patients who are candidates for surgery for supratentorial brain tumors. 2022-12-31 anticipated 30 Complete https://irct.ir/trial/67358 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are grouped using a simple randomization method by rolling dice. In this way, if the tap comes, the S group will be selected and if the line comes, the M group will be selected, Blinding description: Before performing anesthesia, an anesthesiologist who will not be involved in the next stages of the study will determine the patient's group using dice and the patient will receive the drug intervention according to his/her group. The anesthesiologist in charge of the patient will record the information and deliver it to the researcher in a sealed envelope. 3 Supratentorial tumor. Intervention 1: Intervention group: In the mannitol (M) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement. Intervention 2: Intervention group: In the hypertonic saline (S) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: A year after the publication of the article To whom: All jobs Conditions: All non-personal information related to the research can be accessed by contacting the corresponding author. Where to obtain: E-mail to the corresponding author How to obtain: Email submission and review by the responsible author Comments:
public Sohrab Salimi
No. 1, Nilofar Alley, Bahram North, Pourheidari St., Quitarieh
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2221 2058 ssalimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Sohrab Salimi
No. 1, Nilofar Alley, Bahram North, Pourheidari St., Quitarieh
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2221 2058 ssalimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Consent to study Age above 18 years 18 years no limit Both Absence of heart failure History of diseases affecting coagulation Recent use of drugs affecting coagulation Absence of renal failure Absence of liver failure D43.0 Neoplasm of uncertain behavior of brain, supratentorial Treatment - Drugs Treatment - Drugs Intervention group: In the mannitol (M) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement. Intervention group: In the hypertonic saline (S) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement. Closing time. Timepoint: Twenty minutes after drug injection in each of the two groups. Method of measurement: Using PFA100 laboratory test. Shahid Beheshti University of Medical Sciences Approved 2018-11-04 The ethical commite of Shahid Beheshti University of Medical Science Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)