Clinical trial NCT02475187: Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture
Official title: Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thromboembolism
Keywords: TEG
MEA
Thrombotic events
VTE
LMWH
Hip fractures
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to our hospital for proximal femur fracture and receive orthopedic surgery with concomittant thrombosis prophylaxis with LMWH or anticoagulation with Warfarin, and are capable to sign/accept informed concent

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture.
timeFrame: 24 months
Secondary outcomes:
measure: Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) in 220 patients with Hip Fracture.
timeFrame: 6 months
measure: Measurements of thrombogenic properties by TEG (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Kongsberg
country: Norway
facility: Kongsberg Hospital, Vestre Viken Hospital Trust
Study officials:
affiliation: Kongsberg Hospital, Vestre Viken Hospital trust
name: Øystein Meen, Phd
role: PRINCIPAL_INVESTIGATOR
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