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Completed

NCT Number: NCT02150720

Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

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.

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Key information

Conditions

Hip Fracture Blood Loss Femoral Fractures Fractures, Bone Hemorrhage Hip Fractures Hip Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Germans Trias i Pujol de Badalona, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

1g intra-articular before closing the wound surgery

Other names: Amchafibrin

Fibrin glue

Drug

5mL intra-articular before closing the wound surgery

Other names: Evicel

Electrocauterization

Procedure

Coagulation blood from vessels by means of a electrocautery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Proportion of patients requiring blood transfusion

    Time frame: The first postoperative ten days

  3. Units of blood transfused

    Time frame: The first postoperative ten days

  4. Proportion of patients with wound infection

    Time frame: The first postoperative month

  5. Proportion of patients with wound dehiscence

    Time frame: The first postoperative month

  6. Deep venous thrombosis

    Time frame: The first postoperative ten days

  7. Length of hospital stay

    Time frame: The first postoperative ten days

    Time from hip surgery until hospital discharge

  8. 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

  9. Mortality

    Time frame: During the 12 month of follow-up after surgery

  10. Direct cost

    Time frame: During the first postoperative month

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: TRANEXFER

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 30, 2014
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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