thro-fract15: Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture
Study Details
Study Description
Brief Summary
Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 .
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 years who are admitted to our hospital for orthopedic surgery of proximal femur fracture.
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The study participants must be capable to sign/accept informed concent
Exclusion Criteria:
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Patients with severe dementia or that of other causes not ar capable to give informed concent.
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Patients with known or suspected cancer, blood diseases or bleeding disorders
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Surgery last 6 months
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Severe renal- (eGFR (creatinine) <30)
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Severe hepatic failure (2x UNL for bilirubin, 3x UNL for ALAT or INR > 1,3 without anticoagulation treatment)
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Patients that, by drug spesification or -SPC, not are eligible for postoperative thrombosis prophylaxis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kongsberg Hospital, Vestre Viken Hospital Trust | Kongsberg | Norway | 3611 |
Sponsors and Collaborators
- Vestre Viken Hospital Trust
Investigators
- Principal Investigator: Øystein Meen, Phd, Kongsberg Hospital, Vestre Viken Hospital trust
Study Documents (Full-Text)
None provided.More Information
Publications
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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.
- Kornblith LZ, Kutcher ME, Redick BJ, Calfee CS, Vilardi RF, Cohen MJ. Fibrinogen and platelet contributions to clot formation: implications for trauma resuscitation and thromboprophylaxis. J Trauma Acute Care Surg. 2014 Feb;76(2):255-6; discussion 262-3. doi: 10.1097/TA.0000000000000108.
- McCrath DJ, Cerboni E, Frumento RJ, Hirsh AL, Bennett-Guerrero E. Thromboelastography maximum amplitude predicts postoperative thrombotic complications including myocardial infarction. Anesth Analg. 2005 Jun;100(6):1576-1583. doi: 10.1213/01.ANE.0000155290.86795.12.
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- Sibbing D, Schulz S, Braun S, Morath T, Stegherr J, Mehilli J, Schömig A, von Beckerath N, Kastrati A. Antiplatelet effects of clopidogrel and bleeding in patients undergoing coronary stent placement. J Thromb Haemost. 2010 Feb;8(2):250-6. doi: 10.1111/j.1538-7836.2009.03709.x. Epub 2009 Nov 28.
- 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.
- 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.
- Wilson D, Cooke EA, McNally MA, Wilson HK, Yeates A, Mollan RA. Changes in coagulability as measured by thrombelastography following surgery for proximal femoral fracture. Injury. 2001 Dec;32(10):765-70.
- 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.
- REK 2015/139