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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Venous Thromboembolism

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Trial Information

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


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?


Inclusion Criteria:



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

Exclusion Criteria:

- currently receiving anticoagulation therapy

- pregnant

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer

Outcome Time Frame:

3 months post-discharge from hospital

Safety Issue:

No

Principal Investigator

Sara Cheng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

12-1295

NCT ID:

NCT01608919

Start Date:

November 2012

Completion Date:

July 2015

Related Keywords:

  • Venous Thromboembolism
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

Name

Location

University of Colorado HospitalDenver, Colorado  80262