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

Thromboembolism Clinical Trial

— thro-fract15  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475187
• Other study ID #: REK 2015/139
• Status: Terminated
• Start date: September 2015
• Est. completion date: February 1, 2018

Study information

• Verified date: April 2021
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Femoral Fractures
• Thromboembolism

Locations

Country	Name	City	State
Norway	Kongsberg Hospital, Vestre Viken Hospital Trust	Kongsberg

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (11)

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

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. — View Citation

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

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. — View Citation

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):1576-83. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

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