NCT03231787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

4.2 years

First QC Date

July 19, 2017

Last Update Submit

January 18, 2023

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

  • Time from emergency admission to surgery

    Time from emergency admission to surgery will be measured in hours

    Up to 120 hours

Secondary Outcomes (11)

  • Bleeding

    Through hospitalization, an average of 5 days

  • Need for blood transfusion

    Through hospitalization, an average of 5 days

  • Preoperative hemoglobin

    12 hours before surgery

  • Postoperative hemoglobin

    From 12 hours after surgery until date of discharge, an average of 5 days

  • Surgical wound complications

    1 week and 30 days after surgery

  • +6 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Diagnostic Test: Platelet function assay

Control group

NO INTERVENTION

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

Interventions

Platelet function assayDIAGNOSTIC_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.

Also known as: Plateletworks®
Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Maria J Martinez Zapata, MD, PhD

    Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 27, 2017

Study Start

September 4, 2017

Primary Completion

November 17, 2021

Study Completion

December 17, 2021

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

ES(3)