Trials / Completed
CompletedNCT03231787
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-09-04
- Primary completion
- 2021-11-17
- Completion
- 2021-12-17
- First posted
- 2017-07-27
- Last updated
- 2023-01-19
Locations
3 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT03231787. Inclusion in this directory is not an endorsement.