Application of Tranexamic acid in prostatectomy surgery

Phase 2

Recruiting

Conditions: Fibrinolysis and bleeding during open prostatectomy.
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
T81.0

Registration Number: IRCT20170805035510N6

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 40

Inclusion Criteria

Patients who are undergoing open prostatectomy surgery with spinal anesthesia

Exclusion Criteria

Administration of general anesthesia (patients who do not consent for spinal anesthesia or failure of spinal anesthesia)
Previous history of deep vein thrombosis, pulmonary emboli or myocardial infarction
Patients who receive packed red blood cells within one week of surgery
Hemoglobin level lower than 10 mg/dl
Use of anticoagulant drugs (Warfarin, Heparin, etc) within one month of surgery
Use of antiplatete medications (Clopidogrel, Aspirin, etc) within one month of surgery
Previous diagnosis of coagulopathy
Patients who are assigned to the American Society of Anesthesiologists physical status classification of III or higher

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss. Timepoint: At the end of surgery. Method of measurement: The volume of blood absorbed by surgical gauze was estimated using Gauze Visual Analogue method. The mentioned figures plus the amount of blood in the surgical suction pump was considered as the total amount of intraoperative blood loss.;Transfusion of packed red blood cell. Timepoint: During the surgery. Method of measurement: the number of transfused PC were recorded.

Secondary Outcome Measures

Name	Time	Method
Fibrinolysis (based on rotational thromboelastometry analysis). Timepoint: before intervention and at the end of surgery. Method of measurement: rotational thromboelastometry (ROTEM).