Prevention of Postoperative Bleeding in Subcapital Femoral Fractures (TRANEXFER)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Completed; Phase 3

Conditions: Hip Fracture; Blood Loss

Treatments: Procedure: Electrocauterization; Drug: Tranexamic Acid; Drug: Fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT02150720

IIBSP-FAT-2011-103

EC11-341 (Other Grant/Funding Number)

2011-006278-15 (EudraCT Number)

SA/12/AYU/456 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 3 patient groups

Tranexamic acid

Experimental group

Description:

Tranexamic acid, 1g intra-articular before closing the surgery wound

Treatment:

Procedure: Electrocauterization

Drug: Tranexamic Acid

Fibrin glue

Experimental group

Description:

One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,

Treatment:

Procedure: Electrocauterization

Drug: Fibrin glue

Usual hemostasia

Active Comparator group

Description:

Electrocauterization

Treatment:

Procedure: Electrocauterization