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

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

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 Overview

• Status: Completed
• Conditions: Femur Fracture
• Intervention / Treatment: Diagnostic test: Platelet function assay

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Barcelona
    • Manresa, Barcelona, Spain
      • Althaia, xarxa assistencial universitaria de Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.; Other Names: Plateletworks®
No Intervention: Control group; The control group will wait for the safety time of the drug according to the usual practice of the center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from emergency admission to surgery	Time from emergency admission to surgery will be measured in hours	Up to 120 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Total blood loss calculated by Nadler's formula from date of surgery until date of discharge	Through hospitalization, an average of 5 days
Need for blood transfusion	Need for blood transfusion during hospitalization and transfused units	Through hospitalization, an average of 5 days
Preoperative hemoglobin	Measurement of preoperative hemoglobin during 12 h before surgery	12 hours before surgery
Postoperative hemoglobin	Measurement of postoperative hemoglobin until discharge	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	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.	1 week and 30 days after surgery
Platelet Functionality	Measurement of platelet functionality with plateletworks	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	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	From date of admission until the date of first movilization, an average of 3 days
Mortality	All causes mortality	1 year
Cost effectiveness ratio	Cost effectiveness ratio (Δ cost / Δ effectiveness)	1 year

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Carlos III Health Institute; Spanish Clinical Research Network - SCReN
• Investigators: Principal Investigator: Maria J Martinez Zapata, MD, PhD, Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: IIBSP-PLA-2016-86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No