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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400504
First Posted: November 17, 2006
Last Update Posted: November 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose

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
Cancer

Study Type: Observational
Study Design: 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®)

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment: 500
Study Start Date: November 2006
  Eligibility

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
Criteria

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


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

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Principal Investigator: Louise Bochsen, MSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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 Submitted: November 16, 2006
First Posted: November 17, 2006
Last Update Posted: November 17, 2006
Last Verified: November 2006

Keywords provided by Rigshospitalet, Denmark:
Thrombelastograph
Cancer
Thromboembolism
Hypercoagulable

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases