Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery

Study Overview
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Brief Summary
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National, randomized, open, parallel, multicenter clinical trial of two comparison groups that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the surgery time in antiaggregated patients with proximal femur fracture. The experimental group will undergo surgery as soon as platelet aggregability, according to the PLATELETWORKS® method is correct within 24-48 hours. The control group will undergo surgery according to the usual practice of the center taking into account the safety time of the antiplatelet agent.

Official Title
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Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)

Conditions
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Femur Fracture

Intervention / Treatment
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* Diagnostic Test: Platelet function assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients of both sexes Patients with a proximal femoral fracture requiring surgery Patients receiving antiplatelet agents at the time of admission to the emergency room: AAS> 100 mg / d (Aspirin®), Trifusal> 300 mg / d (Digren®; Edigen®), clopidogrel (Plavix®), prasugrel ®), ticagrelor (Brilique ®) and ticlopidine (Tiklid ®). Patients who give their signed consent Exclusion Criteria: Multiple fractures Pathological fractures Patients receiving vitamin K antagonist oral anticoagulants (warfarin and acenocoumarol) or new oral anticoagulants (apixaban, rivaroxaban and dabigatran) or who have acquired congenital or acquired coagulopathy Patients with AAS ≤100mg, trifusal ≤300mg Patients who do not give their informed consent or their legal guardian

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>In this group the platelet aggregability will be evaluated and if it is normal, the surgery will be performed within 24-48 hours. If it is not normal, the evaluation of platelet aggregability will be repeated daily until the third day or until it is normalized if it is earlier. If at the third day is not normalized, it will proceed as with the control group, which will take into account the safety time of the drug. | Diagnostic Test: Platelet function assay<br>* Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation or % platelet inhibition. It will be used to measure platelet function after withdrawal of the antiplatelet agent. If there are more than 80,000 functional platelets, the patient will be operated on within the next 24 hours.<br>* Other names: Plateletworks®;|
| No Intervention: Control group<br>The control group will wait for the safety time of the drug according to the usual practice of the center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from emergency admission to surgery | Time from emergency admission to surgery will be measured in hours | Up to 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Total blood loss calculated by Nadler's formula from date of surgery until date of discharge | Through hospitalization, an average of 5 days | 
| Need for blood transfusion | Need for blood transfusion during hospitalization and transfused units | Through hospitalization, an average of 5 days | 
| Preoperative hemoglobin | Measurement of preoperative hemoglobin during 12 h before surgery | 12 hours before surgery | 
| Postoperative hemoglobin | Measurement of postoperative hemoglobin until discharge | From 12 hours after surgery until date of discharge, an average of 5 days | 
| Surgical wound complications | It includes: Wound infection Wound dehiscence Reoperation due to wound complications Postoperative pain Safety: including the incidence of deep venous thrombosis during admission | 1 week and 30 days after surgery | 
| Medical complications | Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium. | 1 week and 30 days after surgery | 
| Platelet Functionality | Measurement of platelet functionality with plateletworks | From date of admission until the day before surgery, an average of 2 days | 
| Quality of life | Quality of life measured by EQ-5D-5L questionnaire | Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery | 
| Time to admission to patient movilization | Time to admission to patient movilization measured in days | From date of admission until the date of first movilization, an average of 3 days | 
| Mortality | All causes mortality | 1 year | 
| Cost effectiveness ratio | Cost effectiveness ratio (Δ cost / Δ effectiveness) | 1 year |