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NCT Number: NCT03231787

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

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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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet function assay

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.

Other names: Plateletworks®

Primary outcomes

  1. Time from emergency admission to surgery

    Time frame: Up to 120 hours

    Time from emergency admission to surgery will be measured in hours

Secondary outcomes

  1. Bleeding

    Time frame: Through hospitalization, an average of 5 days

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

  2. Need for blood transfusion

    Time frame: Through hospitalization, an average of 5 days

    Need for blood transfusion during hospitalization and transfused units

  3. Preoperative hemoglobin

    Time frame: 12 hours before surgery

    Measurement of preoperative hemoglobin during 12 h before surgery

  4. Postoperative hemoglobin

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

    Measurement of postoperative hemoglobin until discharge

  5. Surgical wound complications

    Time frame: 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

  6. Medical complications

    Time frame: 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.

  7. Platelet Functionality

    Time frame: From date of admission until the day before surgery, an average of 2 days

    Measurement of platelet functionality with plateletworks

  8. Quality of life

    Time frame: Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery

    Quality of life measured by EQ-5D-5L questionnaire

  9. Time to admission to patient movilization

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

    Time to admission to patient movilization measured in days

  10. Mortality

    Time frame: 1 year

    All causes mortality

  11. Cost effectiveness ratio

    Time frame: 1 year

    Cost effectiveness ratio (Δ cost / Δ effectiveness)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Carlos III Health Institute
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)

Acronym: AFFEcT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2017
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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