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

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ClinicalTrials.gov Identifier: NCT03231787
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Carlos III Health Institute
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.


Condition or disease Intervention/treatment Phase
Femur Fracture Diagnostic Test: Platelet function assay Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : December 17, 2018
Estimated Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231787


Contacts
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Contact: Maria J Martinez Zapata, MD, PhD +34935537901 mmartinezz@santpau.cat

Locations
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Spain
Althaia, Xarxa Assistencial Universitària de Manresa Not yet recruiting
Manresa, Barcelona, Spain
Contact: Francesca J Reguant, MD, PhD       freguant@althaia.cat   
Principal Investigator: Francesca Reguant, MD, PhD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Mireia Rodriguez, MD, PhD       mrodriguezpr@santpau.cat   
Principal Investigator: Mireia Rodriguez, MD, PhD         
Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Domingo Blanco, MD, PhD       15228dbv@gmail.com   
Principal Investigator: Domingo Blanco, MD, PhD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Carlos III Health Institute
Spanish Clinical Research Network - CAIBER
Investigators
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Principal Investigator: Maria J Martinez Zapata, MD, PhD Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03231787     History of Changes
Other Study ID Numbers: IIBSP-PLA-2016-86
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries