Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection
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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. |
- 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 |
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| Contact: Angela M Almagro, BSN | 303-724-3596 | angela.almagro@ucdenver.edu |
| Contact: Elizabeth Luzier, RN | 303-724-3597 | elizabeth.luzier@ucdenver.edu |
| 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 | |
| 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 June 17, 2013