NCT02475187

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

May 31, 2015

Last Update Submit

April 14, 2021

Conditions

Thromboembolism

Keywords

TEGMEAThrombotic eventsVTELMWHHip fractures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to our hospital for proximal femur fracture and receive orthopedic surgery with concomittant thrombosis prophylaxis with LMWH or anticoagulation with Warfarin, and are capable to sign/accept informed concent

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kongsberg Hospital, Vestre Viken Hospital Trust

Kongsberg, 3611, Norway

Location

Related Publications (11)

  • 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.

    PMID: 15886800BACKGROUND

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

    PMID: 21262444BACKGROUND

  • 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.

    PMID: 15920177BACKGROUND

  • 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.

    PMID: 19461090BACKGROUND

  • 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.

    PMID: 24076493BACKGROUND

  • 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.

    PMID: 19943882BACKGROUND

  • 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.

    PMID: 24458031BACKGROUND

  • 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.

    PMID: 24246241BACKGROUND

  • 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.

    PMID: 11754883BACKGROUND

  • 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.

    PMID: 23425732BACKGROUND

  • 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.

    PMID: 21079953BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests for Measurments of thrombotic properies. No storage of specimens

MeSH Terms

Conditions

ThromboembolismHip Fractures

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Øystein Meen, Phd

    Kongsberg Hospital, Vestre Viken Hospital trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2015

First Posted

June 18, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

NO(1)