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Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, November 2006
First Received: November 16, 2006   No Changes Posted
Sponsored by: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00400504
  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: Screening, Longitudinal, Defined Population, Prospective Study
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cancer

Exclusion Criteria:

  • Mamma cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers: TEG-Onkologi
Study First Received: November 16, 2006
Last Updated: November 16, 2006
ClinicalTrials.gov Identifier: NCT00400504     History of Changes
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Thrombelastograph
Cancer
Thromboembolism
Hypercoagulable

Study placed in the following topic categories:
Hematologic Diseases
Thrombophilia
Thromboembolism

Additional relevant MeSH terms:
Hematologic Diseases
Thrombophilia

ClinicalTrials.gov processed this record on September 03, 2009