Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Treatments: Fibrin Tissue Adhesive; Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients over 18 years

• Patients with unilateral subcapital femoral fracture

• Patients requiring hip replacement (total or partial)

• Signed informed consent from the patient or legal representative

Exclusion Criteria:

• Known allergy to fibrin glue and tranexamic acid

• Multiple fractures

• Pathological fractures

• Contraceptives or estrogen therapy

• Use of blood salvage during surgery

• History compatible with thromboembolic disease:

• Cerebral vascular accident

• Ischemic heart disease (myocardial infarction, angina )

• Deep vein thrombosis

• Pulmonary Embolism

• Peripheral arterial vasculopathy

• Patients with thrombogenic arrhythmias

• Patients with cardiovascular stents

• Prothrombotic alterations in coagulation