]>
IRCT20180404039188N2 IRCT 2021-05-10 Shahid Beheshti University of Medical Sciences Effect of Tranexamic Acid on blood loss in Pelvic and Acetabular fractures Effect of Intravenous Tranexamic Acid on blood loss in Pelvic and Acetabular fractures in patients referred to Taleghani and Emam Hosein Hospital of Tehran between 2019-2020 2019-03-21 anticipated 108 Complete https://irct.ir/trial/51816 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization for 2 groups (1 Control, and 1 intervention groups), will done using software, 54 random numbers for each group. The surgeon can not play a role in predicting treatment of the disease, and choosing the type of treatment. Random sequence will generate by software. All admitted patients will be placed in one of the groups according to the pre-determined code, Blinding description: Allocation concealment was assured using opaque, sealed envelopes. The anesthesia technician received the envelope and administered either tranexamic prior to the procedure. The patient was given general anesthesia and was unaware of the received treatment and remained blinded after surgery. Two envelopes with the same information about treatment allocation were created. The second envelope was given to the nurse for postoperative drug administration. 3 Condition 1: Fracture of acetabulum. Condition 2: Fracture of pelvis. Intervention 1: Intervention group: Intervention group will receive 15 milligrams per kilogram intravenous tranexamic acid dissolved in 500 milliliters of normal saline 30 minutes prior to start of surgery. Intervention 2: Control group: Control group will receive equivalent volume of normal saline 30 minutes prior to start of surgery. Yes - There is a plan to make this available What will be shared: The data including age, gender, history of diseases (Coronary artery disease, diabetes and Hypertension) and other considered variable will be shared after deidentification. When: Data will be available in 6 months after publication. To whom: People working in academic institutions Conditions: Any type of analysis is prohibited unless the person in charge of the research is informed and would permit. Where to obtain: Reza Zandi Address: Aarabi St. - Yaman St. - Shahid Chamran Highway - Tehran Email: reza.zandi@sbmu.ac.ir How to obtain: Doing the letter writing accordance with the person in charge of the research Comments:
public Reza Zandi
Aarabi st.-Yaman st.-Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1111 reza.zandi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza Zandi
Velenjak
Tehran Iran (Islamic Republic of) 3545415545 +98 21 2240 2020 reza.zandi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with pelvic fractures Patients with acetabular fractures 18 years no limit Both Age below 18 S32.40 S32.9 Unspecified fracture of acetabulum Fracture of unspecified parts of lumbosacral spine and pelvis Treatment - Drugs Placebo Intervention group: Intervention group will receive 15 milligrams per kilogram intravenous tranexamic acid dissolved in 500 milliliters of normal saline 30 minutes prior to start of surgery. Control group: Control group will receive equivalent volume of normal saline 30 minutes prior to start of surgery. Estimated blood loss during surgery. Timepoint: End of surgery. Method of measurement: Estimated Blood Loss(in milliliter)=1000*((hemoglobin level before sugery - hemoglobin after surgery) * total body volume + transfused allogeneic hemoglobin). Post-op drained blood. Timepoint: Last day of hospitalization. Method of measurement: Perception and by using drainage bag. Vein thrombosis of lower limb. Timepoint: three months. Method of measurement: color doppler ultrasonography if patient has related symptoms. Pulmonary embolism. Timepoint: three months. Method of measurement: Lung CT angiography if patient has related symptoms. Drug-associated reaction. Timepoint: three months. Method of measurement: Questionnaire based on drug-associated reaction symptoms answered by patient. Shahid Beheshti University of Medical Sciences Approved 2020-09-23 Ethics committee of Shahid Beheshti University of medical sciences Koodakyar deadend, Daneshjou Boulevard, Yaman street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)