Tranexamic Acid in Major Vascular Surgery

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Blood Loss, Surgical

Treatments: Drug: Placebo; Drug: tranexamic acid undiluted (continous infusion); Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT02335359

Tranex-AAA/34/OSR

Details and patient eligibility

About

The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 50
• Able to give written informed consent
• Undergoing open abdominal aortic aneurysm repair

Exclusion criteria

• Patients participating in a pharmaceutical clinical trial in the last 3 months
• Urgent/emergent surgery
• Allergy/intolerance to tranexamic acid
• History of seizures
• Acute Venous or Arterial Thrombosis
• Fibrinolytic conditions due to consumption coagulopathy
• Disseminated intravascular coagulation
• Haematuria
• Visual disturbances

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.

Treatment:

Drug: tranexamic acid undiluted (continous infusion)

Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose)

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Placebo