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Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
NCT05517811 · University of Colorado, Denver
In plain English
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Official title
Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG
About this study
Aim 1: Evaluate the correlation between pre-operative TEG parameters and disease burden in patients with a new diagnosis of hepatopancreaticobiliary, esophageal, colorectal, and lung adenocarcinoma vs controls with no known malignancy.
Aim 2: Explore if pre- and post-operative TEG parameters vs routine clinical coagulation parameters (platelet count, prothrombin time \[PT\], partial thromboplastin time \[PTT\]) are predictive of pre- and post-operative thrombotic (deep vein thrombosis \[DVT\], pulmonary embolism \[PE\], stroke, myocardial infarct \[MI\]) and hemorrhagic complications.
Aim 3: Evaluate if correction of TEG parameters after surgery is predictive of curative resection and if the failure of TEG parameters to correct after surgery or chemoradiothearpy is predictive of cancer recurrence and overall survival.
Aim 4: Perform proteomic analyses on the tumor microenvironment of cancer tissue samples to investigate whether tumor histology and protein composition is associated with specific TEG derangements that have been previously correlated to poor outcomes, potentially identifying a specific subtype of pancreatic cancer.
Eligibility criteria
Inclusion Criteria:
* new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study
* 18 Years and older
Exclusion Criteria:
* Under 18 years old
* prisoners
* those unable to provide informed consent
* pregnant women
* and those undergoing emergent or urgent operative intervention at the time of diagnosis
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-06-26
Estimated completion: 2028-07-31
Last updated: 2025-01-28
Interventions
Diagnostic Test: TEG indices
Primary outcomes
- • TEG indices of coagulation (One Year)
- • Disease burden as measured by TNM staging (One year)
- • Pre- operative thrombotic and hemorrhagic complications. (One Year)
Sponsor
University of Colorado, Denver · other
With: Haemonetics Corporation
Contacts & investigators
ContactTracey MacDermott, BA BS CCRC · contact · tracey.macdermott@cuanschutz.edu · 303-724-2757
ContactIvan Rodriguez, MD · contact · ivan.rodriguez@cuanschutz.edu
InvestigatorAna Gleisner, MD · principal_investigator, University of Colorado, Denver
All locations (1)
University of Colorado DenverRecruiting
Aurora, Colorado, United States