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

Primary Purpose

Venous Thromboembolism

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

blood tests

About this trial

This is an interventional diagnostic trial for Venous Thromboembolism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

currently receiving anticoagulation therapy
pregnant

Sites / Locations

University of Colorado Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

diagnostic blood tests

Arm Description

We are using 2 standard approved blood tests that may be useful in predicting who may develop a venous thromboembolism after cancer surgery.

Outcomes

Primary Outcome Measures

Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer

Secondary Outcome Measures

Full Information

NCT ID

NCT01608919

First Posted

May 29, 2012

Last Updated

August 7, 2015

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT01608919

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

Sara Cheng, MD has left the University of Colorado and we have closed this study.

Study Start Date

November 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diagnostic blood tests

Arm Type

No Intervention

Arm Description

We are using 2 standard approved blood tests that may be useful in predicting who may develop a venous thromboembolism after cancer surgery.

Intervention Type

Other

Intervention Name(s)

blood tests

Intervention Description

thromboelastogram platelet mapping

Primary Outcome Measure Information:

Title

Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer

Time Frame

3 months post-discharge from hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subjects who are having primary, open resection surgery of gastrointestinal or bladder cancer Exclusion Criteria: currently receiving anticoagulation therapy pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Cheng, MD, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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