Hip FracturesNCT04642209
Aggregometry in Elderlies With Hip Fracture and Receiving Clopidogrel
An observational study of Hip Fractures and Clopidogrel, Poor Metabolism of, run by University Magna Graecia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Clopidogrel, Poor Metabolism of, Anesthesia
- What is being tested?
- Aggregometry
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 30 Dec 2020
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Aggregometry to Drive the Surgical Timing in Elderlies With Hip Fracture and Receiving Clopidogrel.
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.
Read the detailed description
Hip fracture is an established and recognized health problem associated with the age of the population. In the elderly, it is essential that surgery for hip fractures would be performed within 48 hours from admission. Whenever delayed beyond 48 hours, the probability of 30-day mortality increases by 41% and the odds of one-year mortality by 32%.
Neuraxial anesthesia and/or peripheral nerve block are generally preferred in elderlies. However, cardiovascular and/or cerebral comorbidities require antiplatelets therapies at home. This treatment precludes the possibility of an optimal anesthesiologic strategy (i.e., loco-regional anesthesia) within the recommended surgical timing. Therefore, an individual approach is required to balance the risk of drugs continuation/cessation on major cardiovascular events and on peri-operative bleeding.
Clopidogrel is a second-generation thienopyridine antiplatelet drug, that exerts its effect by the inhibition of the platelet's purinergic receptor P2Y12, preventing adenosine diphosphate (ADP) from stimulating it. In patients needing surgery, guidelines recommend withholding clopidogrel 5 days before. However, around 30% of patients are resistant to clopidogrel for several reasons. Patients resistant to clopidogrel may be identify through the thromboelastography (TEG). TEG is a resonance-frequency viscoelastic point-of-care diagnostic system that assesses hemostasis and response to antiplatelet therapy, in combination with the ADP Platelet Mapping assay kit.
It has been hypothesized that the assessment of platelet aggregation with TEG and ADP Platelet Mapping may identify patients resistant to clopidogrel, not requiring to wait for 5 days for hip replacement surgery. We have therefore designed this protocol to guide anesthesiologists in the management of elderlies receiving clopidogrel and requiring surgery for hip fracture. The aim of this pilot study is to evaluate if in a small population of patients, our protocol based on platelet function monitoring would anticipate surgery within 48 hours at least in 70% of elderly patients receiving clopidogrel.
- Conditions
- Hip Fractures, Clopidogrel, Poor Metabolism of, Anesthesia
- Being tested
- Aggregometry
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AggregometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aggregometry | surgical timing will be guided by the results obtained by aggregometry Receives: Device: Aggregometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients undergoing to hip replacement surgery
Number of patients undergoing to hip replacement surgery within 48 hours from hospital admission
Measured: within 48 hours from hospital admission
Secondary outcomes (3)
Occurrence of peri or post-operative complications
Occurrence of peri or post-operative complications, such as postoperative myocardial infarction, thromboembolism, and postoperative confusion
Measured: 28 days from admission
Occurrence of intra-operative hypotension
Reduction of mean arterial pressure by 10% from baseline
Measured: During surgery
Presence of post-operative bleeding
Presence of post-operative bleeding greater than 600 ml, considered as clinically relevant
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Study chair, Magna Graecia University, Anesthesia and Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642209
- Sponsor's protocol ID
- Teg-Femur
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared on reasonable request to the corresponding author
Publications
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.
PubMed 16554334Kristensen 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.
PubMed 25127426Warlo 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.
PubMed 31198410Tarrant 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.
PubMed 32304474Yang 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.
PubMed 32164755Price 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.
PubMed 22698488Tescione 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.
PubMed 33956283
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Aggregometry to Drive the Surgical Timing in Elderlies With Hip Fracture and Receiving Clopidogrel.
- ClinicalTrials.gov ID
- NCT04642209
- Acronym / sponsor ID
- Teg-Femur
- Conditions
- Hip Fractures, Clopidogrel, Poor Metabolism of, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Nov 2020 (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.
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.
Detailed description
Hip fracture is an established and recognized health problem associated with the age of the population. In the elderly, it is essential that surgery for hip fractures would be performed within 48 hours from admission. Whenever delayed beyond 48 hours, the probability of 30-day mortality increases by 41% and the odds of one-year mortality by 32%.
Neuraxial anesthesia and/or peripheral nerve block are generally preferred in elderlies. However, cardiovascular and/or cerebral comorbidities require antiplatelets therapies at home. This treatment precludes the possibility of an optimal anesthesiologic strategy (i.e., loco-regional anesthesia) within the recommended surgical timing. Therefore, an individual approach is required to balance the risk of drugs continuation/cessation on major cardiovascular events and on peri-operative bleeding.
Clopidogrel is a second-generation thienopyridine antiplatelet drug, that exerts its effect by the inhibition of the platelet's purinergic receptor P2Y12, preventing adenosine diphosphate (ADP) from stimulating it. In patients needing surgery, guidelines recommend withholding clopidogrel 5 days before. However, around 30% of patients are resistant to clopidogrel for several reasons. Patients resistant to clopidogrel may be identify through the thromboelastography (TEG). TEG is a resonance-frequency viscoelastic point-of-care diagnostic system that assesses hemostasis and response to antiplatelet therapy, in combination with the ADP Platelet Mapping assay kit.
It has been hypothesized that the assessment of platelet aggregation with TEG and ADP Platelet Mapping may identify patients resistant to clopidogrel, not requiring to wait for 5 days for hip replacement surgery. We have therefore designed this protocol to guide anesthesiologists in the management of elderlies receiving clopidogrel and requiring surgery for hip fracture. The aim of this pilot study is to evaluate if in a small population of patients, our protocol based on platelet function monitoring would anticipate surgery within 48 hours at least in 70% of elderly patients receiving clopidogrel.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aggregometry | – | Device: Aggregometrysurgical timing will be guided by the results obtained by aggregometry |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- pre-existing coagulopathies
- assumption of any anticoagulant oral therapy
- platelet count <100.000 mcL
- pre-existing liver disease
- known autoimmune diseases
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 |
|---|---|---|
| AggregometryAfter 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. | Device | Aggregometry |
Primary outcome
Patients undergoing to hip replacement surgery
Time frame: within 48 hours from hospital admission
Number of patients undergoing to hip replacement surgery within 48 hours from hospital admission
3 secondary outcomes
Occurrence of peri or post-operative complications
Time frame: 28 days from admission
Occurrence of intra-operative hypotension
Time frame: During surgery
Presence of post-operative bleeding
Time frame: Within 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 16554334Bottle 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.
- Background: PubMed 25127426Kristensen 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.
- Background: PubMed 31198410Warlo 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.
- Background: PubMed 32304474Tarrant 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.
- Background: PubMed 32164755Yang 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.
- Background: PubMed 22698488Price 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.
- Derived from this study: PubMed 33956283Tescione 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.
- Individual participant dataSharing planned: Yes. data will be shared on reasonable request to the corresponding author
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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.
Federico Longhini, MD study chair
Magna Graecia University, Anesthesia and Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Clopidogrel, Poor Metabolism of, run by University Magna Graecia at 1 site in Italy.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Longhini, MD (00393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients undergoing to hip replacement surgery (time frame: within 48 hours from hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642209, which also lists 7 linked publications.
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 24 Nov 2020.