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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608919
Recruitment Status : Terminated (Sara Cheng, MD has left the University of Colorado and we have closed this study.)
First Posted : May 31, 2012
Last Update Posted : August 10, 2015
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thromboembolism Other: blood tests Not Applicable

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?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection.
Study Start Date : November 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer [ Time Frame: 3 months post-discharge from hospital ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Colorado, Denver Identifier: NCT01608919     History of Changes
Other Study ID Numbers: 12-1295
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases