Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection

This study has been terminated.
(Sara Cheng, MD has left the University of Colorado and we have closed this study.)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: May 29, 2012
Last updated: August 7, 2015
Last verified: August 2015
This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.

Condition Intervention
Venous Thromboembolism
Other: blood tests

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection.

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer [ Time Frame: 3 months post-discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: November 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: diagnostic blood tests
We are using 2 standard approved blood tests that may be useful in predicting who may develop a venous thromboembolism after cancer surgery.
Other: blood tests
thromboelastogram platelet mapping

Detailed Description:
Venous Thromboembolism (VTE) after cancer surgery hospitalization is the most common cause of death at 30 days after cancer surgery, and is a significant source of patient morbidity and health care cost. Pharmacoprophylaxis has proven efficacy in preventing post-discharge VTE in surgical cancer patients, but perceived risks and costs pose barriers to widespread adoption by clinicians. Risk stratification of this patient population is necessary to allow appropriate prescription of prophylaxis to the highest risk patients. Can the investigators develop a risk stratification model that includes a readily available laboratory test, the thromboelastogram with or without platelet mapping?

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • subjects who are having primary, open resection surgery of gastrointestinal or bladder cancer

Exclusion Criteria:

  • currently receiving anticoagulation therapy
  • pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT01608919

United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Sara Cheng, MD, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver Identifier: NCT01608919     History of Changes
Other Study ID Numbers: 12-1295
Study First Received: May 29, 2012
Last Updated: August 7, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on November 25, 2015