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

Not Applicable

Terminated

• Conditions: Venous Thromboembolism
• Interventions: Other: blood tests

• Registration Number: NCT01608919
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Study Start: 2012-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-07
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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Exclusion Criteria

• currently receiving anticoagulation therapy
• pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diagnostic blood tests	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.

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer	3 months post-discharge from hospital

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States