Clincosm LogoSign in Get a demo

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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT00400504
Collaborator
(none)
500
Enrollment
1
Location

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
    Study Start Date :
    Nov 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Clinical diagnosis of cancer
      Exclusion Criteria:
      • Mamma cancer

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Rigshospitalet Copenhagen Denmark DK-2100

      Sponsors and Collaborators

      • Rigshospitalet, Denmark

      Investigators

      • Study Chair: Pär I Johansson, MD, Rigshospitalet, Denmark
      • Study Director: Gedske Daugaard, MD, Rigshospitalet, Denmark

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00400504
      Other Study ID Numbers:
      • TEG-Onkologi
      First Posted:
      Nov 17, 2006
      Last Update Posted:
      Nov 17, 2006
      Last Verified:
      Nov 1, 2006
      Keywords provided by , ,
      Thrombelastograph
      Cancer
      Thromboembolism
      Hypercoagulable
      Additional relevant MeSH terms:
      Thrombophilia

      Study Results

      No Results Posted as of Nov 17, 2006