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IRCT20190129042541N1 IRCT 2019-02-13 vice chancellor of research . shiraz university of medical sciences investigate efficacy of fibrinogen blood level correction and bleeding valume in traumatic brain injury investigate efficacy of fibrinogen blood level correction between 1.5 - 2 gr/lit to above 2 gr/lit with bleeding rate during operation and post operation hospital course in traumatic brain injury 2019-03-21 anticipated 30 Complete https://irct.ir/trial/37214 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomizaing with coin flipping (head or tail), if flipped coin shows head (picture side of coin) ,we put patient in fibrinogen corrected group and if flipped coin shows tail (amount of money coin side coin) ,we put patient in fibrinogen in uncorrected group. 3 intra cranial bleeding in traumatic brain injury. Intervention group: pre operation or during surgery intra venous fibrinogen injection was down patient. , if serum fibrinogen level is between 175 to 200 mg per lit, one gram fibrinogen was injected ,and if serum fibrinogen level is between 150 to 200mg per lit, two gram fibrinogen was injected. Yes - There is a plan to make this available What will be shared: all data except personal patients data When: 6 months after data publication To whom: all researcher Conditions: no extra condition Where to obtain: researcher should refer to emtiaz hospital How to obtain: Written request from amin niakan Comments:
public Amin Niakan
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 aniakan@sums.ac.ir Shiraz University of Medical Sciences scientific Amin Niakan
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 aniakan@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) patients who are older than sixteen years and brought to Emtiaz hospital ER, affiliated to Shiraz Univercity of medical sciemces,Shiraz, Iran, between March 2019 to March 2020 and underwent skull craniotomy whom fibrinogen level is between 1.5 to 2.0 gr/lit are include in our study 16 years 65 years Both patients who have coagulopathy in lab data such as abnormal PTwe exclude the patients who have coagulopathy in lab data such as abnormal PT,PTT,INR, platelets counts or history of coagulopathy disorders or underwent another major surgery from other services in this admission before skull craniotomy surgery from our study S06 Intracranial injury Treatment - Drugs Intervention group: pre operation or during surgery intra venous fibrinogen injection was down patient. , if serum fibrinogen level is between 175 to 200 mg per lit, one gram fibrinogen was injected ,and if serum fibrinogen level is between 150 to 200mg per lit, two gram fibrinogen was injected Blood volume rate. Timepoint: pre operatio and post operation. Method of measurement: blood volume messurment during operation and in hemovac and post operatin, blood volume messurment in pre and post operation CT scan. vice chancellor of research . shiraz university of medical sciences Approved 2019-01-26 •Ethics committee of Shiraz University of Medical Sciences Emtiaz Hospital, shahid chamran Blvd Shiraz Fars Iran (Islamic Republic of)