Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

Hip Fracture Clinical Trial

— TRANEXFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150720
• Other study ID #: IIBSP-FAT-2011-103
• Secondary ID: EC11-3412011-006
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2014
• Last updated: September 19, 2016
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: March 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Femoral Fractures
• Fractures, Bone
• Hemorrhage
• Hip Fracture
• Hip Fractures
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid
1g intra-articular before closing the wound surgery
• Fibrin glue
5mL intra-articular before closing the wound surgery

Procedure:
• Electrocauterization
Coagulation blood from vessels by means of a electrocautery.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol de Badalona	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitari Mútua Terrassa	Terrassa	Barcelona
Spain	Hospital Universitari Terrassa-Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Proportion of patients requiring blood transfusion		The first postoperative ten days	No
Secondary	Units of blood transfused		The first postoperative ten days	No
Secondary	Proportion of patients with wound infection		The first postoperative month	Yes
Secondary	Proportion of patients with wound dehiscence		The first postoperative month	Yes
Secondary	Deep venous thrombosis		The first postoperative ten days	Yes
Secondary	Length of hospital stay	Time from hip surgery until hospital discharge	The first postoperative ten days	No
Secondary	Quality of life measured with the generic EQ-5D -5L		Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up	No
Secondary	Mortality		During the 12 month of follow-up after surgery	Yes
Secondary	Direct cost		During the first postoperative month	No

External Links

•   Publication of quality of life (subgroup of patients)