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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

156

Conditions

Femur Fracture

Interventions

Platelet function assay

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time from emergency admission to surgery

Time from emergency admission to surgery will be measured in hours

Time frame: Up to 120 hours

Secondary Outcomes

Bleeding

Total blood loss calculated by Nadler's formula from date of surgery until date of discharge

Time frame: Through hospitalization, an average of 5 days

Need for blood transfusion

Need for blood transfusion during hospitalization and transfused units

Time frame: Through hospitalization, an average of 5 days

Preoperative hemoglobin

Measurement of preoperative hemoglobin during 12 h before surgery

Time frame: 12 hours before surgery

Postoperative hemoglobin

Measurement of postoperative hemoglobin until discharge

Time frame: 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

Time frame: 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.

Time frame: 1 week and 30 days after surgery

Platelet Functionality

Measurement of platelet functionality with plateletworks

Time frame: 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

Time frame: 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

Time frame: From date of admission until the date of first movilization, an average of 3 days

Mortality

All causes mortality

Time frame: 1 year

Cost effectiveness ratio

Cost effectiveness ratio (Δ cost / Δ effectiveness)