Femur FractureAFFEcTNCT03231787
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
A study testing Platelet function assay in people with Femur Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Platelet function assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 3 sitesSpain
- Study dates
- 4 Sep 2017to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Vall d'Hebron
Barcelona
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona
About this study
Official title: 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.
- Conditions
- Femur Fracture
- Being tested
- Platelet function assay
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet function assayDiagnostic test
Also called Plateletworks®
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Diagnostic Test: Platelet function assay |
| Control group | No intervention | The control group will wait for the safety time of the drug according to the usual practice of the center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from emergency admission to surgery
Time from emergency admission to surgery will be measured in hours
Measured: Up to 120 hours
Secondary outcomes (11)
Bleeding
Total blood loss calculated by Nadler's formula from date of surgery until date of discharge
Measured: Through hospitalization, an average of 5 days
Need for blood transfusion
Need for blood transfusion during hospitalization and transfused units
Measured: Through hospitalization, an average of 5 days
Preoperative hemoglobin
Measurement of preoperative hemoglobin during 12 h before surgery
Measured: 12 hours before surgery
Postoperative hemoglobin
Measurement of postoperative hemoglobin until discharge
Measured: 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
Measured: 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.
Measured: 1 week and 30 days after surgery
Platelet Functionality
Measurement of platelet functionality with plateletworks
Measured: 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
Measured: 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
Measured: From date of admission until the date of first movilization, an average of 3 days
Mortality
All causes mortality
Measured: 1 year
Cost effectiveness ratio
Cost effectiveness ratio (Δ cost / Δ effectiveness)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start4 Sep 2017
- Primary completion17 Nov 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Maria J Martinez Zapata, MD, PhD, Principal investigator, Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231787
- Sponsor's protocol ID
- IIBSP-PLA-2016-86
- Acronym
- AFFEcT
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
- ClinicalTrials.gov ID
- NCT03231787
- Acronym / sponsor ID
- AFFEcT / IIBSP-PLA-2016-86
- Conditions
- Femur Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, Spanish Clinical Research Network - SCReN
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: Platelet function assayIn 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. |
| Control group | No intervention | –The control group will wait for the safety time of the drug according to the usual practice of the center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet function assayAlso: Plateletworks®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. | Diagnostic test | Experimental group |
Primary outcome
Time from emergency admission to surgery
Time frame: Up to 120 hours
Time from emergency admission to surgery will be measured in hours
11 secondary outcomes
Bleeding
Time frame: Through hospitalization, an average of 5 days
Need for blood transfusion
Time frame: Through hospitalization, an average of 5 days
Preoperative hemoglobin
Time frame: 12 hours before surgery
Postoperative hemoglobin
Time frame: From 12 hours after surgery until date of discharge, an average of 5 days
Surgical wound complications
Time frame: 1 week and 30 days after surgery
Medical complications
Time frame: 1 week and 30 days after surgery
Platelet Functionality
Time frame: From date of admission until the day before surgery, an average of 2 days
Quality of life
Time frame: Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery
Time to admission to patient movilization
Time frame: From date of admission until the date of first movilization, an average of 3 days
Mortality
Time frame: 1 year
Cost effectiveness ratio
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria J Martinez Zapata, MD, PhD principal investigator
Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet function assay in people with Femur Fracture, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from emergency admission to surgery (time frame: Up to 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.