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IRCT20191013045091N1 IRCT 2020-01-30 Shahid Beheshti University of Medical Sciences Prophylactic Fibrinogen and perioperative bleeding Prophylactic Fibrinogen effect on perioperative bleeding in radical cystectomy: a double-blind randomized placebo-controlled study 2019-12-15 anticipated 35 Complete https://irct.ir/trial/44160 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple Random Sampling using table of random numbers, Blinding description: the study group will receive 2 grams of fibrinogen in 100 cc of distilled water by an anesthetist 30 min before surgery and control group will receive the same amount of normal saline, the anesthesiologist will know only the patients who had received fibrinogen. 3 Condition 1: Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a genitourinary system procedure. Condition 2: Acquired absence of other parts of urinary tract. Condition 3: Malignant neoplasm of bladder, unspecified. Intervention 1: Intervention group: receive 2 grams of fibrinogen in 100 cc distilled water. Intervention 2: Control group: receive 100 cc normal saline. Yes - There is a plan to make this available What will be shared: all data sets will be sahred When: 6 months after publication To whom: available for people working in academic institutions Conditions: no criteria Where to obtain: m.ariannik@sbmu.ac.ir How to obtain: proof of academic Comments:
public Mohsen Arian nik
No 3, Block 10, First Vahdat st, East Laleh, South Jannat Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1473855744 +98 21 4447 7493 m.ariannik@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohsen Arian nik
No 3, Block 10, First Vahdat st, East Laleh, South Jannat Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1473855744 +98 21 4447 7493 m.ariannik@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years old Admitted for elective radical cystectomy localized bladder cancer (T1–2N0M0) 18 years no limit Both Anticoagulant agent Having a known blood Abnormality or coagulopathy (abnormal values of platelet count, PT, APTT, fibrinogen, antithrombin, or Ddimer) A history of thromboembolism Chronic liver disease Chronic kidney disease with a serum creatinine level of > 2 mg/dl A preoperative plasma fibrinogen level of ≥ 400 mg/dl intake of non-steroidal anti-inflammatory drugs within 2 days prior to surgery N99.61 Z90.6 C67.9 Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a genitourinary system procedure Acquired absence of other parts of urinary tract Malignant neoplasm of bladder, unspecified Prevention Placebo Intervention group: receive 2 grams of fibrinogen in 100 cc distilled water Control group: receive 100 cc normal saline Blood loss during surgery. Timepoint: at the end of surgery. Method of measurement: visual evaluation. Shahid Beheshti University of Medical Sciences Approved 2019-05-05 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)