Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue

Conditions
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Hip Fracture, Blood Loss

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Fibrin glue
* Procedure: Electrocauterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Tranexamic acid, 1g intra-articular before closing the surgery wound | Drug: Tranexamic Acid<br>* 1g intra-articular before closing the wound surgery<br>* Other names: Amchafibrin;Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery.<br>|
| Experimental: Fibrin glue<br>One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery, | Drug: Fibrin glue<br>* 5mL intra-articular before closing the wound surgery<br>* Other names: Evicel;Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery.<br>|
| Active Comparator: Usual hemostasia<br>Electrocauterization | Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidden blood loss | 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 |  | 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 | 
| Deep venous thrombosis |  | The first postoperative ten days | 
| Length of hospital stay | Time from hip surgery until hospital discharge | The first postoperative ten days | 
| Quality of life measured with the generic EQ-5D -5L |  | Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up | 
| Mortality |  | During the 12 month of follow-up after surgery | 
| Direct cost |  | During the first postoperative month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, Hip fractures, Clinical Trial, Randomized, Fibrin glue, Blood loss