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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2021-12-17

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.

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Detailed Description

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Conditions

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Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Platelet function assay

Intervention Type DIAGNOSTIC_TEST

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.

Control group

The control group will wait for the safety time of the drug according to the usual practice of the center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Plateletworks®

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No