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IRCT20190729044375N1 IRCT 2021-01-31 Kermanshah University of Medical Sciences Effect of cryopercipitate in trauma patients with brain contusion Clinical trial to compare the effect of cryopericiptate and conventional treatment on prevention of brain contusion expansion in trauma patients 2021-02-08 anticipated 50 Complete https://irct.ir/trial/41201 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the block randomization method individuals are divided into two equal groups. Randomization process will be done using blocks of size 6 and 8. Blocking will already be done by random software online, Blinding description: Double blind_The physician who collects data, the physician who is responsible for patient care, the analyst and the patient included in the plan are unaware of who receives cryopercipitate or or is in the control group. 2-3 Brain contusion expansion in traumatic patients(ICH; IVH, Brain Contusion). Intervention 1: Intervention group: In addition to receivig conservative routine care; intravenous adminestration of 4 units of cryoprecipitate prepared in Iranian Blood Transfusion Organization which contains coagulation factors (fibrinogen& 8&13&VWF) in nonpregnant traumatic patient above 18y/o who have no history of blood factor deficiency disease.( routine and conservative care:ICU admission and control of GCS and anticonvulsant therapy). Intervention 2: Control group:In this grouo patients with brain contusion due to trauma who are nonpregnant; above18y/o and have no history of blood factor deficiency disease are only under routine conservative care(ICU admission and control of GCS and anticonvulsant therapy). Yes - There is a plan to make this available What will be shared: All data collected in the research (including: age, gender, height, weight, lab.data and radiologic finding) can be shared after making people unidentifiable. When: Three months after announcement the results To whom: Only researchers working in academic institution Conditions: This research will be done on limitted number of people; but its results can be cited in meta_ analyze. Where to obtain: Dr. Mohammd Reza Akrami. Address: Department of neurosurgery; Taleghani hospital affiliated to Kermanshah University of Medical Sciences. Email address: mmdakramu@yahoo.com How to obtain: After confirming that the applicant has the conditions to receive the information ( the researcher working in a university or scientific institute) the information will be provided to him/ her as soon as possible. Comments:
public Dr.Mohamamdreza Akrami
Taleghani hospital; Shahid Beheshti boulevard
Kermanshah Iran (Islamic Republic of) 6715847167 +98 83 3837 8098 alireza.tahmoures@gmail.com Kermanshah University of Medical Sciences scientific Dr.Mohammadreza Akrami
Taleghani hospital; Shahid Beheshti boulevard
Kermanshah Iran (Islamic Republic of) 671584167 +98 83 3835 7752 alireza.tahmoures@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Traumatic brain contusion or brain hematoma Over 18 years of age Their legal guardian allowance 18 years no limit Both History of blood hemostatic factor deficiency Candidate for emergency brain hemorrhage surgery Pregnancy S06.3 Focal traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: In addition to receivig conservative routine care; intravenous adminestration of 4 units of cryoprecipitate prepared in Iranian Blood Transfusion Organization which contains coagulation factors (fibrinogen& 8&13&VWF) in nonpregnant traumatic patient above 18y/o who have no history of blood factor deficiency disease.( routine and conservative care:ICU admission and control of GCS and anticonvulsant therapy) Control group:In this grouo patients with brain contusion due to trauma who are nonpregnant; above18y/o and have no history of blood factor deficiency disease are only under routine conservative care(ICU admission and control of GCS and anticonvulsant therapy). Size of brain tissue hematoma. Timepoint: At the time of admission and 6, 12, 24 and 48 hours after admission. Method of measurement: Size determination on CT scan graph by radiologist. Kermanshah University of Medical Sciences Approved 2021-01-16 Ethics committee of Kermanshah University of Medicine Sciences Taleghani hospital; Shahid Beheshti boulevard Kermanshah Kermanshah Iran (Islamic Republic of)