Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture

Study Overview
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Brief Summary
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Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.

Detailed Description
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Patients with proximal femur fracture have high incidences of thrombotic events. By the two bed-side methods TEG (Thrombelastography) and MEA (Multiple Electrode Aggregometry), the thrombogenic properties of 220 patients with proximal femur fracture will be measured at time of hospital admission and 4 times over a period of 6 months postoperatively, and the patients will be followed in a total length of 2 years to register thrombotic events.

Official Title
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Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture

Conditions
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Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years who are admitted to our hospital for orthopedic surgery of proximal femur fracture. The study participants must be capable to sign/accept informed concent Exclusion Criteria: Patients with severe dementia or that of other causes not ar capable to give informed concent. Patients with known or suspected cancer, blood diseases or bleeding disorders Surgery last 6 months Severe renal- (eGFR (creatinine) <30) Severe hepatic failure (2x UNL for bilirubin, 3x UNL for ALAT or INR > 1,3 without anticoagulation treatment) Patients that, by drug spesification or -SPC, not are eligible for postoperative thrombosis prophylaxis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture. | Thrombogenic properties measured by TEG (different measurements as MA) and MEA (measured as U) 6 months after operation for hip fracture and clinical thrombotic events over 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) in 220 patients with Hip Fracture. | Measurements of thrombogenic properties by TEG and MEA in 220 patients patients with Hip Fracture to investigate any correlation between the two Methods and anti-fXa titer. | 6 months | 
| Measurements of thrombogenic properties by TEG (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications | Measurements of thrombogenic properties by TEG and MEA (in the first) 100 patients with Hip Fracture and . | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEG, MEA, Thrombotic events, VTE, LMWH, Hip fractures