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

Terminated

• Conditions: Thromboembolism

• Registration Number: NCT02475187
• Lead Sponsor: Vestre Viken Hospital Trust

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.

Study Timeline

• Study First Submitted: 2015-05-31
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-18
• Study Start: 2015-09
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 .

Trial Locations

Locations (1)

Kongsberg Hospital, Vestre Viken Hospital Trust; 🇳🇴 Kongsberg, Norway