Prevention of Postoperative Bleeding in Subcapital Femoral Fractures (TRANEXFER)

September 19, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic
      • 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 Tauli
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mutua Terrassa
      • Terrassa, Barcelona, Spain, 08227
        • Hospital Universitari Terrassa-Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood loss (ml) after surgery
Time Frame: The first postoperative 24h
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with wound infection
Time Frame: The first postoperative month
The first postoperative month
Proportion of patients with wound dehiscence
Time Frame: The first postoperative month
The first postoperative month
Hidden blood loss
Time Frame: 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.
The first postoperative five days
Proportion of patients requiring blood transfusion
Time Frame: The first postoperative ten days
The first postoperative ten days
Units of blood transfused
Time Frame: The first postoperative ten days
The first postoperative ten days
Deep venous thrombosis
Time Frame: The first postoperative ten days
The first postoperative ten days
Length of hospital stay
Time Frame: The first postoperative ten days
Time from hip surgery until hospital discharge
The first postoperative ten days
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
Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
Mortality
Time Frame: During the 12 month of follow-up after surgery
During the 12 month of follow-up after surgery
Direct cost
Time Frame: During the first postoperative month
During the first postoperative month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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