Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
|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
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:
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Observational Model:||Defined Population|
|Official Title:||Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)|
|Study Start Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400504
|Contact: Louise Bochsen, MScfirstname.lastname@example.org|
|Copenhagen, Denmark, DK-2100|
|Principal Investigator: Louise Bochsen, MSc|
|Study Chair:||Pär I Johansson, MD||Rigshospitalet, Denmark|
|Study Director:||Gedske Daugaard, MD||Rigshospitalet, Denmark|