Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau161 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

161

Conditions

Hip Fracture Blood Loss

Interventions

Tranexamic AcidDRUG

1g intra-articular before closing the wound surgery

Fibrin glueDRUG

5mL intra-articular before closing the wound surgery

ElectrocauterizationPROCEDURE

Coagulation blood from vessels by means of a electrocautery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hospital Germans Trias i Pujol de Badalona

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Clinic

Barcelona, Barcelona, Spain

Parc Taulí

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Blood loss (ml) after surgery

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 Outcomes

Hidden blood loss

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

Proportion of patients requiring blood transfusion

Time frame: The first postoperative ten days

Units of blood transfused

Time frame: The first postoperative ten days

Proportion of patients with wound infection

Time frame: The first postoperative month

Proportion of patients with wound dehiscence

Time frame: The first postoperative month

Deep venous thrombosis

Time frame: The first postoperative ten days

Length of hospital stay

Time from hip surgery until hospital discharge

Time frame: 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

Mortality

Data from ClinicalTrials.gov

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