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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02475187

Acronym

thro-fract15

Enrollment

Registered

2015-06-18

Start date

2015-09-30

Completion date

2018-02-01

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

TEG, MEA, Thrombotic events, VTE, LMWH, Hip fractures

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture.	24 months	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

Secondary

Measure	Time frame	Description
Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) in 220 patients with Hip Fracture.	6 months	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.
Measurements of thrombogenic properties by TEG (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications	6 months	Measurements of thrombogenic properties by TEG and MEA (in the first) 100 patients with Hip Fracture and .

Countries

Norway

Outcome results