Clinical trial NCT03231787: Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
Official title: Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Spanish Clinical Research Network - SCReN
First posted: 2017-07-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from emergency admission to surgery
timeFrame: Up to 120 hours
Secondary outcomes:
measure: Bleeding
timeFrame: Through hospitalization, an average of 5 days
measure: Need for blood transfusion
timeFrame: Through hospitalization, an average of 5 days
measure: Preoperative hemoglobin
timeFrame: 12 hours before surgery
measure: Postoperative hemoglobin
timeFrame: From 12 hours after surgery until date of discharge, an average of 5 days
measure: Surgical wound complications
timeFrame: 1 week and 30 days after surgery
measure: Medical complications
timeFrame: 1 week and 30 days after surgery
measure: Platelet Functionality
timeFrame: From date of admission until the day before surgery, an average of 2 days
measure: Quality of life
timeFrame: Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery
measure: Time to admission to patient movilization
timeFrame: From date of admission until the date of first movilization, an average of 3 days
measure: Mortality
timeFrame: 1 year
measure: Cost effectiveness ratio
timeFrame: 1 year
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
name: Maria J Martinez Zapata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: