]>
IRCT20191208045664N1 IRCT 2019-12-19 Tabriz University of Medical Sciences effect of tranxamic acid on blood loss and need to transfusion in pelvic surgery the effect of systemic and local injection of tranxamic acid on blood loss and need to transfusion in acetabulum surgery (Transverse, T Type and associated fracture) 2020-01-21 anticipated 100 Complete https://irct.ir/trial/44093 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, clinical caregivers and patients participating in the study will be blind. All patients will be aware of the benefits and potential consequences of clinical trial, but They will be unaware about who will receive the intervention. All patients will be treated by a surgeon and he will be blind about tranexamic acid order. Tranexsamic acid transfusion will be administered just before surgery by an anesthesiologist. Topical injection will be applied to all patients in 30 cc solution at the end of surgery. some of them will receive placebo(normal saline solution). after 3 week of surgery, patients will be evaluated for vascular thrombosis by color Doppler ultrasound by a Radiologist. He will not be aware of the group who give intervention. 3 Acetabulum fracture. Intervention 1: Intervention group: Before surgical excision of this group, they will be infused with 1 gram of tranexamic acid dissolved in 100 ml of normal saline. 3 grams of tranexamic acid dissolved in 30 cc normal saline is applied topically at the site of surgery after the end of surgery. Intervention 2: Control group: The control group received no injection of tranexamic acid and The placebo will use in the field of surgery. Yes - There is a plan to make this available What will be shared: After the study, all data will be shared after unidentifiable individuals When: after 6 months of publication, data will be accessible To whom: The study data will be available only to researchers working in academic institutions Conditions: Due to the unrecognizable people, no restrictions will apply Where to obtain: Aliasghar Tanha Phone Number: 00989127940833 Email: Tanha_med@yahoo.com How to obtain: After making a call and stating the reason for the need for data, he will be provided with the requested items between 1-2 weeks Comments:
public Aliasghar Tanha
Shohada hospital, baharestan, golshahr, il goli, tabriz
Tabriz Iran (Islamic Republic of) 3395193573 +98 21 3608 0425 Tanha_med@yahoo.com Tabriz University of Medical Sciences scientific Aliasghar Tanha
Shohada hospital, baharestan, golshahr, il goli, tabriz
Tabriz Iran (Islamic Republic of) 3395193573 +98 21 3608 0425 Tanha_med@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patient over 18 year's old with T Type, Transverse and associated acetabular fracture 18 years no limit Both sensitive to tranxamic acid history of thrombotic disease coagulopathy disorder renal and hepatic function disorder patient with multi fracture who need multiple surgery history of CVA history of coronary stent Patients treated with anticoagulants massive transfusion before surgery sensitive to drugs patients treat with anticoagulats S32.4 Fracture of acetabulum Treatment - Drugs Treatment - Drugs Intervention group: Before surgical excision of this group, they will be infused with 1 gram of tranexamic acid dissolved in 100 ml of normal saline. 3 grams of tranexamic acid dissolved in 30 cc normal saline is applied topically at the site of surgery after the end of surgery. Control group: The control group received no injection of tranexamic acid and The placebo will use in the field of surgery Hemoglobin level. Timepoint: before surgery, 24 and 48he after surgery. Method of measurement: with automatic cell counter in laboratory. Deep vein thrombosis. Timepoint: 3 weeks after surgery. Method of measurement: with color doppler sonography by the radiologist. Bleeding volume. Timepoint: during and after surgery. Method of measurement: The volume of the suction tank, the number of gases-stained with blood, and bleeding of the surgery field. volume of the hemovak drain after surgery. Blood transfuion. Timepoint: Before surgery; after 24 and 48hr of surgery. Method of measurement: According to Hb level. Tabriz university of medical science Approved 2019-12-08 Ethics committee of Tabriz University of Medical Sciences Shohada Hospital, Golshahr, Baharestan, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)