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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Time from emergency admission to surgery [ Time Frame: Up to 120 hours ]Time from emergency admission to surgery will be measured in hours
- 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
- Need for blood transfusion [ Time Frame: Through hospitalization, an average of 5 days ]Need for blood transfusion during hospitalization and transfused units
- Preoperative hemoglobin [ Time Frame: 12 hours before surgery ]Measurement of preoperative hemoglobin during 12 h before surgery
- Postoperative hemoglobin [ Time Frame: From 12 hours after surgery until date of discharge, an average of 5 days ]Measurement of postoperative hemoglobin until discharge
- Surgical wound complications [ Time Frame: 1 week and 30 days after surgery ]
- Wound infection
- Wound dehiscence
- Reoperation due to wound complications
- Postoperative pain
- Safety: including the incidence of deep venous thrombosis during admission
- 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.
- Platelet Functionality [ Time Frame: From date of admission until the day before surgery, an average of 2 days ]Measurement of platelet functionality with plateletworks
- 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
- 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
- Mortality [ Time Frame: 1 year ]All causes mortality
- Cost effectiveness ratio [ Time Frame: 1 year ]Cost effectiveness ratio (Δ cost / Δ effectiveness)
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
|Contact: Maria J Martinez Zapata, MD, PhDfirstname.lastname@example.org|
|Althaia, Xarxa Assistencial Universitària de Manresa||Not yet recruiting|
|Manresa, Barcelona, Spain|
|Contact: Francesca J Reguant, MD, PhD email@example.com|
|Principal Investigator: Francesca Reguant, MD, PhD|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Contact: Mireia Rodriguez, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Mireia Rodriguez, MD, PhD|
|Hospital Vall d'Hebron||Not yet recruiting|
|Contact: Domingo Blanco, MD, PhD email@example.com|
|Principal Investigator: Domingo Blanco, MD, PhD|
|Principal Investigator:||Maria J Martinez Zapata, MD, PhD||Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau|