NCT04642209

Aggregometry in Elderlies With Hip Fracture and Receiving Clopidogrel

Status unknown Last updated 24 November 2020

What this trial tests

trial testing Aggregometry in Hip Fractures in 9 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
15 December 2020

30 December 2020

Quick facts

Lead sponsor	University Magna Graecia
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	9
Start date	1 December 2020
Primary completion	15 December 2020
Estimated completion	30 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Aggregometry

Conditions studied

• Hip Fractures — all drugs for Hip Fractures →
• Clopidogrel, Poor Metabolism of — all drugs for Clopidogrel, Poor Metabolism of →
• Anesthesia — all drugs for Anesthesia →

Sponsor

University Magna Graecia

Who can join

65 and older, any sex, with Hip Fractures or Clopidogrel, Poor Metabolism of. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In elderly patients, hip fracture should be surgically treated within 48 hours from admission, since its deferral worsens the mortality. However, sometimes patients are affected by cardiovascular or cerebral comorbidities, deeming necessary the use of antiplatelets and/or anticoagulant therapies. Clopidogrel is a second-generation thienopyridine antiplatelet drug which exerts its effect by the inhibition of the platelet's purinergic receptor P2Y12 preventing adenosine diphosphate (ADP) from stimulating it. Guidelines recommend to withhold clopidogrel for 5 days before the possibility to perform neuraxial anesthesia, which is frequently the optimal perioperative management of a fragile patient. It should be mentioned however that around 30% of patients are resistant to clopidogrel and they show a normal platelet reactivity despite the antiplatelet therapy. Therefore, in principle, these patients do not require to defer surgery. We have therefore hypothesized that some patients taking clopidogrel might anticipate surgery before 5 days and within 48 hours, following a protocol based on the assessment of coagulation and platelet aggregation through thromboelastography (TEG) in combination with an ADP Platelet Mapping assay kit.

After hospital admission for femur fracture, eligible patients would be evaluated by the anesthesiologist and the orthopedic physicians for anesthesia and surgery. Immediately a sample of blood should be collected for TEG with ADP Platelet Mapping test. If both MA-ADP and platelets aggregation (%) will be within normal values, the patient could be considered as candidate for immediate surgery (within 48 hours) with neuraxial anesthesia and ultrasound-guided antalgic femoral nerve block. If MA-ADP and/or platelets aggregation (%) are lower, risk for mortality should be assessed. If the patient would be considered at high risk for mortality, he/she would undergo to general anesthesia and peripheral antalgic block to not postpone surgery. Otherwise, surgery would be postponed until the normalization of both MA-ADP and platelet aggregation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Platelet aggregometry for hip fracture surgery in patients treated with clopidogrel: a pilot study.
   Tescione M, Vadalà E, Marano G, Battaglia E, et al · · 2022 · cited 1× · PMID 33956283 · DOI 10.1007/s10877-021-00714-z