NCT01608919

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

May 29, 2012

Last Update Submit

August 7, 2015

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism free survival after surgery for gastrointestinal or urologic cancer

    3 months post-discharge from hospital

Study Arms (1)

diagnostic blood tests

NO INTERVENTION

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

Interventions

blood testsOTHER

thromboelastogram platelet mapping

diagnostic blood tests

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • currently receiving anticoagulation therapy
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sara Cheng, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

US(1)