Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

Phase 3

Completed

• Conditions: Hip Fracture; Blood Loss
• Interventions: Drug: Fibrin glue; Drug: Tranexamic Acid; Procedure: Electrocauterization

• Registration Number: NCT02150720
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Primary Completion: 2015-04
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Electrocauterization	Tranexamic acid, 1g intra-articular before closing the surgery wound
Fibrin glue	Fibrin glue	One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
Fibrin glue	Electrocauterization	One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
Usual hemostasia	Electrocauterization	Electrocauterization
Tranexamic acid	Tranexamic Acid	Tranexamic acid, 1g intra-articular before closing the surgery wound

Primary Outcome Measures

Name	Time	Method
Blood loss (ml) after surgery	The first postoperative 24h	The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Hidden blood loss	The first postoperative five days	The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain.
Proportion of patients requiring blood transfusion	The first postoperative ten days
Units of blood transfused	The first postoperative ten days
Proportion of patients with wound infection	The first postoperative month
Proportion of patients with wound dehiscence	The first postoperative month
Deep venous thrombosis	The first postoperative ten days
Length of hospital stay	The first postoperative ten days	Time from hip surgery until hospital discharge
Quality of life measured with the generic EQ-5D -5L	Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
Mortality	During the 12 month of follow-up after surgery
Direct cost	During the first postoperative month

Trial Locations

Locations (6)

Hospital Clinic; 🇪🇸 Barcelona, Spain

Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitari Mútua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitari Terrassa-Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Germans Trias i Pujol de Badalona; 🇪🇸 Badalona, Barcelona, Spain