Prevention of Postoperative Bleeding in Subcapital Femoral Fractures (TRANEXFER)

Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss; Hip Fracture
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Fibrin glue; Procedure: Electrocauterization

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol de Badalona
    • Sabadell, Barcelona, Spain, 08208
      • Parc Taulí
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitari Mutua Terrassa
    • Terrassa, Barcelona, Spain, 08227
      • Hospital Universitari Terrassa-Consorci Sanitari de Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; Tranexamic acid, 1g intra-articular before closing the surgery wound	Drug: Tranexamic Acid; 1g intra-articular before closing the wound surgery; Other Names: Amchafibrin; Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery.
Active Comparator: Usual hemostasia; Electrocauterization	Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery.
Experimental: Fibrin glue; One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,	Drug: Fibrin glue; 5mL intra-articular before closing the wound surgery; Other Names: Evicel; Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with wound infection		The first postoperative month
Proportion of patients with wound dehiscence		The first postoperative month
Hidden blood loss	The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain.	The first postoperative five days
Proportion of patients requiring blood transfusion		The first postoperative ten days
Units of blood transfused		The first postoperative ten days
Deep venous thrombosis		The first postoperative ten days
Length of hospital stay	Time from hip surgery until hospital discharge	The first postoperative ten days
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: MJ Martínez-Zapata, MD, PhD, Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau

Publications and helpful links

General Publications

• Martínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.
• Merchán-Galvis A, Posso M, Canovas E, Jordán M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.

Helpful Links

• Publication of quality of life (subgroup of patients)

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Randomized; Clinical Trial; Hip fractures; Tranexamic acid; Blood loss; Fibrin glue
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Hemorrhage; Fractures, Bone; Hip Fractures; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin Tissue Adhesive; Tranexamic Acid
• Other Study ID Numbers: IIBSP-FAT-2011-103; EC11-341 (Other Grant/Funding Number: Ministry of Health and Social Policy 2011); 2011-006278-15 (EudraCT Number); SA/12/AYU/456 (Other Grant/Funding Number: Fundación MAPFRE 2012)