Tranexamic Acid in Urologic Surgery (TRANEX-URO)

Università Vita-Salute San Raffaele

Status and phase: Completed; Phase 4

Conditions: Prostatectomy; Bleeding

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00670345

GO/URC/ER/mm 139/DG

Details and patient eligibility

About

This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.

200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Patients belonging to the control group will receive the same volume of saline infusions.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients
• Patients undergoing open radical prostatectomy

Exclusion criteria

• Age < 18 years
• Patients with drug eluting stent with a double antiplatelet therapy
• Atrial fibrillation
• Thrombophilic diathesis
• Allergy to tranexamic acid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Treatment:

Drug: Tranexamic Acid

2

Placebo Comparator group

Description:

Patients belonging to the control group will receive the same volume of saline infusions.

Treatment:

Drug: Placebo