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

Vestre Viken Hospital Trust33 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thromboembolism

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kongsberg Hospital, Vestre Viken Hospital Trust

Kongsberg, Norway

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 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 .

Time frame: 6 months

Data from ClinicalTrials.gov

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