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

NCT00400504 | Unknown

• 1 other identifier: TEG-Onkologi
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Cancer

Keywords

Thrombelastograph; Cancer; Thromboembolism; Hypercoagulable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of cancer

You may not qualify if:

• Mamma cancer

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, DK-2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms; Thromboembolism; Thrombophilia

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pär I Johansson, MD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Gedske Daugaard, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Louise Bochsen, MSc

CONTACT

+4535452033; louise.bochsen@rh.hosp.dk

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: November 1, 2006
• Last Updated: November 17, 2006

Record last verified: 2006-11

Locations

DK (1)