Application of Tranexamic acid in prostatectomy surgery

Assessing the efficacy of Tranexamic acid versus placebo in reducing fibrinolysis, blood loss, and transfusion requirements during open prostatectomy surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170805035510N6

Enrollment

Registered

2019-09-17

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: Patients receive tranexamic acid (10mg/kg) diluted in normal saline (100cc) over 30 minutes before initiation of surgery. Intervention 2: Control group: patients re

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients who are undergoing open prostatectomy surgery with spinal anesthesia

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPejman Pourfakhr

Tehran University of Medical Sciences

pourfakhr@tums.ac.ir+98 21 4466 3963

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026