Thromboembolism Clinical Trial
— thro-fract15Official title:
Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture
Verified date | April 2021 |
Source | Vestre Viken Hospital Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.
Status | Terminated |
Enrollment | 33 |
Est. completion date | February 1, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Kongsberg Hospital, Vestre Viken Hospital Trust | Kongsberg |
Lead Sponsor | Collaborator |
---|---|
Vestre Viken Hospital Trust |
Norway,
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Harr JN, Moore EE, Chin TL, Ghasabyan A, Gonzalez E, Wohlauer MV, Banerjee A, Silliman CC, Sauaia A. Platelets are dominant contributors to hypercoagulability after injury. J Trauma Acute Care Surg. 2013 Mar;74(3):756-62; discussion 762-5. doi: 10.1097/TA.0b013e3182826d7e. — View Citation
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Talsnes O, Hjelmstedt F, Dahl OE, Pripp AH, Reikerås O. Clinical and biochemical prediction of early fatal outcome following hip fracture in the elderly. Int Orthop. 2011 Jun;35(6):903-7. doi: 10.1007/s00264-010-1149-7. Epub 2010 Nov 16. — View Citation
Tantry US, Bonello L, Aradi D, Price MJ, Jeong YH, Angiolillo DJ, Stone GW, Curzen N, Geisler T, Ten Berg J, Kirtane A, Siller-Matula J, Mahla E, Becker RC, Bhatt DL, Waksman R, Rao SV, Alexopoulos D, Marcucci R, Reny JL, Trenk D, Sibbing D, Gurbel PA; Working Group on On-Treatment Platelet Reactivity. Consensus and update on the definition of on-treatment platelet reactivity to adenosine diphosphate associated with ischemia and bleeding. J Am Coll Cardiol. 2013 Dec 17;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101. Epub 2013 Sep 27. — View Citation
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Würtz M, Hvas AM, Christensen KH, Rubak P, Kristensen SD, Grove EL. Rapid evaluation of platelet function using the Multiplate® Analyzer. Platelets. 2014;25(8):628-33. doi: 10.3109/09537104.2013.849804. Epub 2013 Nov 18. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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