Aggregometry in Elderlies With Hip Fracture and Receiving Clopidogrel

NCT04642209 | Unknown

• 1 other identifier: Teg-Femur
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; Clopidogrel, Poor Metabolism of; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Patients undergoing to hip replacement surgery

  Number of patients undergoing to hip replacement surgery within 48 hours from hospital admission

  within 48 hours from hospital admission

Secondary Outcomes (3)

• Occurrence of peri or post-operative complications

  28 days from admission

• Occurrence of intra-operative hypotension

  During surgery

• Presence of post-operative bleeding

  Within 48 hours after surgery

Study Arms (1)

Aggregometry

surgical timing will be guided by the results obtained by aggregometry

Device: Aggregometry

Interventions

Aggregometry DEVICE

After evaluation at the Emergency Department the anesthesiologist immediately collects a sample of blood for TEG with ADP Platelet Mapping test. If both MA-ADP and platelets aggregation (%) are within normal values (i.e. ≥45 mm and ≥83%, respectively), the patient could be considered as candidate for immediate surgery (within 48 hours) with neuraxial anesthesia. If MA-ADP and/or platelets aggregation (%) are lower than normal values, the Nottingham Hip Fracture Score (NHFS) is computed, to predict the 30-day mortality after hip fracture surgery. If NHFS is ≥4 (high risk), the patient will undergo to general anesthesia and peripheral antalgic block, to perform surgery within 48 hours. In case of low risk for mortality (i.e. a NHFS \<4), surgery will be postponed until the normalization of both MA-ADP and platelet aggregation.

Aggregometry

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients older than 65 years/old, admitted to the hospital for suspected traumatic femur fracture receiving clopidogrel 75 mg/die at home were consecutively included in the pilot study. Patients with one or more of the following criteria were excluded: 1) pre-existing coagulopathies; 2) assumption of any anticoagulant oral therapy; 3) platelet count \<100.000 mcL; 4) pre-existing liver disease; 5) known autoimmune diseases; 6) presence of hematological malignancies.

You may qualify if:

• all patients older than 65 years/old
• admission to the hospital for suspected traumatic femur fracture
• home therapy with clopidogrel 75 mg/die at home

You may not qualify if:

• pre-existing coagulopathies
• assumption of any anticoagulant oral therapy
• platelet count \<100.000 mcL
• pre-existing liver disease
• known autoimmune diseases
• presence of hematological malignancies

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Federico Longhini

Catanzaro, 88100, Italy

Location

Related Publications (7)

• Bottle A, Aylin P. Mortality associated with delay in operation after hip fracture: observational study. BMJ. 2006 Apr 22;332(7547):947-51. doi: 10.1136/bmj.38790.468519.55. Epub 2006 Mar 22.

  PMID: 16554334 BACKGROUND

• Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.

  PMID: 25127426 BACKGROUND

• Warlo EMK, Arnesen H, Seljeflot I. A brief review on resistance to P2Y12 receptor antagonism in coronary artery disease. Thromb J. 2019 May 20;17:11. doi: 10.1186/s12959-019-0197-5. eCollection 2019.

  PMID: 31198410 BACKGROUND

• Tarrant SM, Kim RG, McGregor KL, Palazzi K, Attia J, Balogh ZJ. Dual Antiplatelet Therapy and Surgical Timing in Geriatric Hip Fracture. J Orthop Trauma. 2020 Oct;34(10):559-565. doi: 10.1097/BOT.0000000000001779.

  PMID: 32304474 BACKGROUND

• Yang Z, Ni J, Long Z, Kuang L, Gao Y, Tao S. Is hip fracture surgery safe for patients on antiplatelet drugs and is it necessary to delay surgery? A systematic review and meta-analysis. J Orthop Surg Res. 2020 Mar 12;15(1):105. doi: 10.1186/s13018-020-01624-7.

  PMID: 32164755 BACKGROUND

• Price MJ, Walder JS, Baker BA, Heiselman DE, Jakubowski JA, Logan DK, Winters KJ, Li W, Angiolillo DJ. Recovery of platelet function after discontinuation of prasugrel or clopidogrel maintenance dosing in aspirin-treated patients with stable coronary disease: the recovery trial. J Am Coll Cardiol. 2012 Jun 19;59(25):2338-43. doi: 10.1016/j.jacc.2012.02.042.

  PMID: 22698488 BACKGROUND

• Tescione M, Vadala E, Marano G, Battaglia E, Bruni A, Garofalo E, Longhini F, Rovida S, Polimeni N, Squillaci R, Lascala S, Franco G, Labate D, Caracciolo M, Macheda S. Platelet aggregometry for hip fracture surgery in patients treated with clopidogrel: a pilot study. J Clin Monit Comput. 2022 Jun;36(3):823-828. doi: 10.1007/s10877-021-00714-z. Epub 2021 May 6.

  PMID: 33956283 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Federico Longhini, MD

  Magna Graecia University, Anesthesia and Intensive Care Unit

  STUDY CHAIR

Central Study Contacts

Federico Longhini, MD

CONTACT

00393475395967; longhini.federico@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 24, 2020
• Study Start: December 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After study publication

Locations

IT (1)