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Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)

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ClinicalTrials.gov Identifier: NCT00400504
Recruitment Status : Unknown
Verified November 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : November 17, 2006
Last Update Posted : November 17, 2006
Information provided by:

Study Description
Brief Summary:

Patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk.

Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention.

In this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies.

The hypotheses of this study are:

  1. Patients with malignancies and hypercoagulability, defined as a TEG MA>69 mm and /or R<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA<69 mm and/or a R>4 min.
  2. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.

Condition or disease

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Study Start Date : November 2006

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U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of cancer

Exclusion Criteria:

  • Mamma cancer
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400504

Contact: Louise Bochsen, MSc +4535452033 louise.bochsen@rh.hosp.dk

Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Principal Investigator: Louise Bochsen, MSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Pär I Johansson, MD Rigshospitalet, Denmark
Study Director: Gedske Daugaard, MD Rigshospitalet, Denmark
More Information

ClinicalTrials.gov Identifier: NCT00400504     History of Changes
Other Study ID Numbers: TEG-Onkologi
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: November 17, 2006
Last Verified: November 2006

Keywords provided by Rigshospitalet, Denmark:

Additional relevant MeSH terms:
Hematologic Diseases