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

Femur Fracture Clinical Trial

— AFFEcT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231787
• Other study ID #: IIBSP-PLA-2016-86
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Althaia, Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Carlos III Health Institute, Spanish Clinical Research Network - SCReN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from emergency admission to surgery	Time from emergency admission to surgery will be measured in hours	Up to 120 hours
Secondary	Bleeding	Total blood loss calculated by Nadler's formula from date of surgery until date of discharge	Through hospitalization, an average of 5 days
Secondary	Need for blood transfusion	Need for blood transfusion during hospitalization and transfused units	Through hospitalization, an average of 5 days
Secondary	Preoperative hemoglobin	Measurement of preoperative hemoglobin during 12 h before surgery	12 hours before surgery
Secondary	Postoperative hemoglobin	Measurement of postoperative hemoglobin until discharge	From 12 hours after surgery until date of discharge, an average of 5 days
Secondary	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
Secondary	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
Secondary	Platelet Functionality	Measurement of platelet functionality with plateletworks	From date of admission until the day before surgery, an average of 2 days
Secondary	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
Secondary	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
Secondary	Mortality	All causes mortality	1 year
Secondary	Cost effectiveness ratio	Cost effectiveness ratio (? cost / ? effectiveness)	1 year