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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01608919
First received: May 29, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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?

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608919

Contacts
Contact: Angela M Almagro, BSN 303-724-3596 angela.almagro@ucdenver.edu
Contact: Elizabeth Luzier, RN 303-724-3597 elizabeth.luzier@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Sub-Investigator: Csaba Gajdos, MD         
Sub-Investigator: Nathan Pearlman, MD         
Sub-Investigator: Paul Wischmeyer, MD         
Sub-Investigator: Martin McCarter, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sara Cheng, MD, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01608919     History of Changes
Other Study ID Numbers: 12-1295
Study First Received: May 29, 2012
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014