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Prevention of Postoperative Bleeding in Subcapital Femoral Fractures (TRANEXFER)

Primary Purpose

Hip Fracture, Blood Loss

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Tranexamic Acid
Fibrin glue
Electrocauterization
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip fractures, Clinical Trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Germans Trias i Pujol de Badalona
  • Parc Taulí
  • Hospital Universitari Mútua Terrassa
  • Hospital Universitari Terrassa-Consorci Sanitari de Terrassa
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Tranexamic acid

Fibrin glue

Usual hemostasia

Arm Description

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

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

Electrocauterization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hidden blood loss
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
Units of blood transfused
Proportion of patients with wound infection
Proportion of patients with wound dehiscence
Deep venous thrombosis
Length of hospital stay
Time from hip surgery until hospital discharge
Quality of life measured with the generic EQ-5D -5L
Mortality
Direct cost

Full Information

First Posted
May 22, 2014
Last Updated
September 19, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT02150720
Brief Title
Prevention of Postoperative Bleeding in Subcapital Femoral Fractures
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Blood Loss
Keywords
Hip fractures, Clinical Trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
Tranexamic acid, 1g intra-articular before closing the surgery wound
Arm Title
Fibrin glue
Arm Type
Experimental
Arm Description
One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
Arm Title
Usual hemostasia
Arm Type
Active Comparator
Arm Description
Electrocauterization
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Amchafibrin
Intervention Description
1g intra-articular before closing the wound surgery
Intervention Type
Drug
Intervention Name(s)
Fibrin glue
Other Intervention Name(s)
Evicel
Intervention Description
5mL intra-articular before closing the wound surgery
Intervention Type
Procedure
Intervention Name(s)
Electrocauterization
Intervention Description
Coagulation blood from vessels by means of a electrocautery.
Primary Outcome Measure Information:
Title
Blood loss (ml) after surgery
Description
The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.
Time Frame
The first postoperative 24h
Secondary Outcome Measure Information:
Title
Hidden blood loss
Description
The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain.
Time Frame
The first postoperative five days
Title
Proportion of patients requiring blood transfusion
Time Frame
The first postoperative ten days
Title
Units of blood transfused
Time Frame
The first postoperative ten days
Title
Proportion of patients with wound infection
Time Frame
The first postoperative month
Title
Proportion of patients with wound dehiscence
Time Frame
The first postoperative month
Title
Deep venous thrombosis
Time Frame
The first postoperative ten days
Title
Length of hospital stay
Description
Time from hip surgery until hospital discharge
Time Frame
The first postoperative ten days
Title
Quality of life measured with the generic EQ-5D -5L
Time Frame
Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
Title
Mortality
Time Frame
During the 12 month of follow-up after surgery
Title
Direct cost
Time Frame
During the first postoperative month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MJ Martínez-Zapata, MD, PhD
Organizational Affiliation
Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol de Badalona
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitari Mútua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitari Terrassa-Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
36045358
Citation
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.
Results Reference
derived
Links:
URL
http://www.mapfre.com/fundacion/html/revistas/trauma/v25n4/docs/v25n4.pdf
Description
Publication of quality of life (subgroup of patients)

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Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

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