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

Primary Purpose

Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Platelet function assay
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femur Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Althaia, Xarxa Assistencial Universitària de Manresa
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time from emergency admission to surgery
Time from emergency admission to surgery will be measured in hours

Secondary Outcome Measures

Bleeding
Total blood loss calculated by Nadler's formula from date of surgery until date of discharge
Need for blood transfusion
Need for blood transfusion during hospitalization and transfused units
Preoperative hemoglobin
Measurement of preoperative hemoglobin during 12 h before surgery
Postoperative hemoglobin
Measurement of postoperative hemoglobin until discharge
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
Medical complications
Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium.
Platelet Functionality
Measurement of platelet functionality with plateletworks
Quality of life
Quality of life measured by EQ-5D-5L questionnaire
Time to admission to patient movilization
Time to admission to patient movilization measured in days
Mortality
All causes mortality
Cost effectiveness ratio
Cost effectiveness ratio (Δ cost / Δ effectiveness)

Full Information

First Posted
July 19, 2017
Last Updated
January 18, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT03231787
Brief Title
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
Acronym
AFFEcT
Official Title
Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will wait for the safety time of the drug according to the usual practice of the center.
Intervention Type
Diagnostic Test
Intervention Name(s)
Platelet function assay
Other Intervention Name(s)
Plateletworks®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time from emergency admission to surgery
Description
Time from emergency admission to surgery will be measured in hours
Time Frame
Up to 120 hours
Secondary Outcome Measure Information:
Title
Bleeding
Description
Total blood loss calculated by Nadler's formula from date of surgery until date of discharge
Time Frame
Through hospitalization, an average of 5 days
Title
Need for blood transfusion
Description
Need for blood transfusion during hospitalization and transfused units
Time Frame
Through hospitalization, an average of 5 days
Title
Preoperative hemoglobin
Description
Measurement of preoperative hemoglobin during 12 h before surgery
Time Frame
12 hours before surgery
Title
Postoperative hemoglobin
Description
Measurement of postoperative hemoglobin until discharge
Time Frame
From 12 hours after surgery until date of discharge, an average of 5 days
Title
Surgical wound complications
Description
It includes: Wound infection Wound dehiscence Reoperation due to wound complications Postoperative pain Safety: including the incidence of deep venous thrombosis during admission
Time Frame
1 week and 30 days after surgery
Title
Medical complications
Description
Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium.
Time Frame
1 week and 30 days after surgery
Title
Platelet Functionality
Description
Measurement of platelet functionality with plateletworks
Time Frame
From date of admission until the day before surgery, an average of 2 days
Title
Quality of life
Description
Quality of life measured by EQ-5D-5L questionnaire
Time Frame
Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery
Title
Time to admission to patient movilization
Description
Time to admission to patient movilization measured in days
Time Frame
From date of admission until the date of first movilization, an average of 3 days
Title
Mortality
Description
All causes mortality
Time Frame
1 year
Title
Cost effectiveness ratio
Description
Cost effectiveness ratio (Δ cost / Δ effectiveness)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria J Martinez Zapata, MD, PhD
Organizational Affiliation
Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Althaia, Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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