Femur Fracture
Conditions
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.
Interventions
DIAGNOSTIC_TESTPlatelet function assay
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.
Sponsors
Carlos III Health Institute
Spanish Clinical Research Network - SCReN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from emergency admission to surgery | Up to 120 hours | Time from emergency admission to surgery will be measured in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for blood transfusion | Through hospitalization, an average of 5 days | Need for blood transfusion during hospitalization and transfused units |
| Preoperative hemoglobin | 12 hours before surgery | Measurement of preoperative hemoglobin during 12 h before surgery |
| Postoperative hemoglobin | From 12 hours after surgery until date of discharge, an average of 5 days | Measurement of postoperative hemoglobin until discharge |
| 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 |
| 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. |
| Bleeding | Through hospitalization, an average of 5 days | Total blood loss calculated by Nadler's formula from date of surgery until date of discharge |
| 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 |
| 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) |
| Platelet Functionality | From date of admission until the day before surgery, an average of 2 days | Measurement of platelet functionality with plateletworks |
Countries
Spain
Outcome results
None listed