Last reviewed · How we verify
NCT03231787: AFFEcT
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
NA trial testing Platelet function assay in Femur Fracture in 156 participants. Completed in 17 December 2021.
17 November 2021
Quick facts
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 156 |
| Start date | 4 September 2017 |
| Primary completion | 17 November 2021 |
| Estimated completion | 17 December 2021 |
| Sites | 3 locations across Spain |
Drugs / interventions tested
- Platelet function assay
Conditions studied
- Femur Fracture — all drugs for Femur Fracture →
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Who can join
18 and older, any sex, with Femur Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial.
Rafael A, Mireia R, José María G, Victoria M, et al · · 2019 · cited 5× · PMID 31083195 · DOI 10.1097/md.0000000000015514 -
Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial.
Anaya R, Rodriguez M, Millan A, Reguant F, et al · · 2021 · cited 3× · PMID 34830654 · DOI 10.3390/jcm10225371 -
Correlation between PlateletWorks<sup>®</sup> and PFA-100<sup>®</sup> for Measuring Platelet Function before Urgent Surgery in Patients with Chronic Antiplatelet Therapy.
Anaya R, Rodriguez M, Gil JM, Vilalta N, et al · · 2021 · cited 2× · PMID 33445597 · DOI 10.3390/jcm10020255 -
Quality of Life and Post-Surgical Complications in Patients on Chronic Antiplatelet Therapy with Proximal Femur Fracture: 12-Month Follow-Up after Implementing a Strategy to Shorten the Time to Surgery.
Merchán-Galvis A, Anaya R, Rodriguez M, Llorca J, et al · · 2023 · cited 1× · PMID 36769778 · DOI 10.3390/jcm12031130
Verify or expand the search:
- PubMed search for NCT03231787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Platelet function assay
Trials testing the same drug.
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Other recruiting trials for Femur Fracture
Currently open trials in the same condition.
- NCT06568770 — Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery · Phase 2, PHASE3 · recruiting
- NCT05514405 — Effect of Remimazolam and Propofol on Postoperative Delirium · NA · recruiting
Other Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials
Trials by the same sponsor.
- NCT07343882 — Quantification of Systemic Congestion by Ultrasound As a Predictor of Weaning Failure From Mechanical Ventilation · NA · not yet recruiting
- NCT07530237 — Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusio · active not recruiting
- NCT07369310 — Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming · NA · not yet recruiting
- NCT07314190 — Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodege · enrolling by invitation
- NCT07239843 — Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychia · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03231787 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Last refreshed: 19 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03231787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing