Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

NCT02150720 | Completed Phase 3

• 4 other identifiers: IIBSP-FAT-2011-103EC11-3412011-006278-15SA/12/AYU/456
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 6

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.

Conditions

Hip Fracture; Blood Loss

Keywords

Hip fractures; Clinical Trial; Randomized; Fibrin glue; Tranexamic acid; Blood loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Hidden blood loss

  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

• Proportion of patients with wound infection

  The first postoperative month

• Proportion of patients with wound dehiscence

  The first postoperative month

Study Arms (3)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic Acid; Procedure: Electrocauterization

Fibrin glue

EXPERIMENTAL

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

Drug: Fibrin glue; Procedure: Electrocauterization

Usual hemostasia

ACTIVE COMPARATOR

Electrocauterization

Procedure: Electrocauterization

Interventions

Tranexamic Acid DRUG

1g intra-articular before closing the wound surgery

Also known as: Amchafibrin

Tranexamic acid

Fibrin glue DRUG

5mL intra-articular before closing the wound surgery

Also known as: Evicel

Fibrin glue

Electrocauterization PROCEDURE

Coagulation blood from vessels by means of a electrocautery.

Fibrin glue; Tranexamic acid; Usual hemostasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Hospital Germans Trias i Pujol de Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitari Mútua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitari Terrassa-Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (2)

• 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.

  RESULT

• Merchan-Galvis A, Posso M, Canovas E, Jordan 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.

  PMID: 36045358 DERIVED

Related Links

• Publication of quality of life (subgroup of patients)

MeSH Terms

Conditions

Hip Fractures; Hemorrhage

Interventions

Tranexamic Acid; Fibrin Tissue Adhesive; Diathermy

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Hyperthermia, Induced; Therapeutics

Study Officials

• MJ Martínez-Zapata, MD, PhD

  Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 30, 2014
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

ES (6)