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

NCT ID: NCT02475187

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Thromboembolism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øystein Meen, Phd

Role: PRINCIPAL_INVESTIGATOR

Kongsberg Hospital, Vestre Viken Hospital trust

Locations

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Kongsberg Hospital, Vestre Viken Hospital Trust

Kongsberg, , Norway

Site Status

Countries

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Norway

References

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Dahl OE, Caprini JA, Colwell CW Jr, Frostick SP, Haas S, Hull RD, Laporte S, Stein PD. Fatal vascular outcomes following major orthopedic surgery. Thromb Haemost. 2005 May;93(5):860-6. doi: 10.1160/TH04-11-0769.

Reference Type BACKGROUND
PMID: 15886800 (View on PubMed)

Cattaneo M. Resistance to anti-platelet agents. Thromb Res. 2011 Feb;127 Suppl 3:S61-3. doi: 10.1016/S0049-3848(11)70017-2.

Reference Type BACKGROUND
PMID: 21262444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15920177 (View on PubMed)

Paniccia R, Antonucci E, Maggini N, Romano E, Gori AM, Marcucci R, Prisco D, Abbate R. Assessment of platelet function on whole blood by multiple electrode aggregometry in high-risk patients with coronary artery disease receiving antiplatelet therapy. Am J Clin Pathol. 2009 Jun;131(6):834-42. doi: 10.1309/AJCPTE3K1SGAPOIZ.

Reference Type BACKGROUND
PMID: 19461090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24076493 (View on PubMed)

Sibbing D, Schulz S, Braun S, Morath T, Stegherr J, Mehilli J, Schomig 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.

Reference Type BACKGROUND
PMID: 19943882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24458031 (View on PubMed)

Wurtz M, Hvas AM, Christensen KH, Rubak P, Kristensen SD, Grove EL. Rapid evaluation of platelet function using the Multiplate(R) Analyzer. Platelets. 2014;25(8):628-33. doi: 10.3109/09537104.2013.849804. Epub 2013 Nov 18.

Reference Type BACKGROUND
PMID: 24246241 (View on PubMed)

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. doi: 10.1016/s0020-1383(01)00139-5.

Reference Type BACKGROUND
PMID: 11754883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23425732 (View on PubMed)

Talsnes O, Hjelmstedt F, Dahl OE, Pripp AH, Reikeras 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.

Reference Type BACKGROUND
PMID: 21079953 (View on PubMed)

Other Identifiers

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REK 2015/139

Identifier Type: -

Identifier Source: org_study_id

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