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

NCT ID: NCT00400504

Last Updated: 2006-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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Thrombelastograph Cancer Thromboembolism Hypercoagulable

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of cancer

Exclusion Criteria

* Mamma cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Pär I Johansson, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Gedske Daugaard, MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Louise Bochsen, MSc

Role: CONTACT

Phone: +4535452033

Email: [email protected]

Other Identifiers

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TEG-Onkologi

Identifier Type: -

Identifier Source: org_study_id