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NCT00400504 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00400504
Other study ID # TEG-Onkologi
Secondary ID
Status Recruiting
Phase N/A
First received November 16, 2006
Last updated November 16, 2006
Start date November 2006

Study information
Verified date November 2006
Source Rigshospitalet, Denmark
Contact Louise Bochsen, MSc
Phone +4535452033
Email louise.bochsen@rh.hosp.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of cancer

Exclusion Criteria:

- Mamma cancer

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

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