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Thromboembolismthro-fract15NCT02475187

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

An observational study of Thromboembolism, run by Vestre Viken Hospital Trust at 1 site in Norway.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Thromboembolism
How many people
33 participants
Where
1 siteNorway
Study dates
Sep 2015to 1 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Kongsberg Hospital, Vestre Viken Hospital Trust

    Kongsberg, 3611

Other trials in Norway

About this study

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

Read the 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.

Conditions
Thromboembolism
Keywords
TEG, MEA, Thrombotic events, VTE, LMWH, Hip fractures
Medical subject headings
Thromboembolism, Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (2)

  1. 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.

    Measured: 6 months

  2. 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 .

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion1 Feb 2018
  4. Study completion1 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475187
Sponsor's protocol ID
REK 2015/139
Acronym
thro-fract15
Status last verified
Apr 2021
First submitted
31 May 2015
Last updated
15 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15886800

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

    PubMed 21262444

  • 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.

    PubMed 15920177

  • 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.

    PubMed 19461090

  • 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.

    PubMed 24076493

  • 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.

    PubMed 19943882

  • 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.

    PubMed 24458031

  • 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.

    PubMed 24246241

  • 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.

    PubMed 11754883

  • 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.

    PubMed 23425732

  • 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.

    PubMed 21079953

Questions about this trial

What is this clinical trial studying?

An observational study of Thromboembolism, run by Vestre Viken Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02475187, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.

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