Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
- Conditions
- Femur Fracture
- Interventions
- Diagnostic Test: Platelet function assay
- Registration Number
- NCT03231787
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Platelet function assay 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.
- Primary Outcome Measures
Name Time Method Time from emergency admission to surgery Up to 120 hours Time from emergency admission to surgery will be measured in hours
- Secondary Outcome Measures
Name Time Method Postoperative hemoglobin From 12 hours after surgery until date of discharge, an average of 5 days Measurement of postoperative hemoglobin until discharge
Platelet Functionality From date of admission until the day before surgery, an average of 2 days Measurement of platelet functionality with plateletworks
Quality of life Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery Quality of life measured by EQ-5D-5L questionnaire
Bleeding Through hospitalization, an average of 5 days Total blood loss calculated by Nadler's formula from date of surgery until date of discharge
Preoperative hemoglobin 12 hours before surgery Measurement of preoperative hemoglobin during 12 h before surgery
Need for blood transfusion Through hospitalization, an average of 5 days Need for blood transfusion during hospitalization and transfused units
Medical complications 1 week and 30 days after surgery Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium.
Time to admission to patient movilization From date of admission until the date of first movilization, an average of 3 days Time to admission to patient movilization measured in days
Mortality 1 year All causes mortality
Cost effectiveness ratio 1 year Cost effectiveness ratio (Δ cost / Δ effectiveness)
Surgical wound complications 1 week and 30 days after surgery It includes:
* Wound infection
* Wound dehiscence
* Reoperation due to wound complications
* Postoperative pain
* Safety: including the incidence of deep venous thrombosis during admission
Trial Locations
- Locations (3)
Althaia, Xarxa Assistencial Universitària de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain