Tranexamic acid in major vascular surgery (Tranex-AAA)

Phase 1

• Conditions: abdominal aortic aneurysm; MedDRA version: 17.0Level: LLTClassification code 10000054Term: Abdominal aortic aneurysmSystem Organ Class: 100000004866; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-001456-39-IT
• Lead Sponsor: IRCCS Ospedale San Raffaele

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age> 50 years
Ability to provide written informed consent
Patient undergoing surgery of abdominal aortic aneurysmectomy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patients who participated in a drug trial in the previous three months
Intervention under the emergency / urgency
Uncooperative patient and / or mental changes
Reported allergy or intolerance to study drug
History of seizures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified