Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection (TEG)

August 21, 2026 updated by: University of Colorado, Denver

Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG

The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Contact:
        • Principal Investigator:
          • Ana Gleisner, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who are evaluated at the University of Colorado Cancer Center with a new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study.

Description

Inclusion Criteria:

  • new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal, lung adenocarcinoma, or liver metastasis of any origin will be eligible for enrollment in the study
  • 18 Years and older

Exclusion Criteria:

  • Under 18 years old
  • prisoners
  • unable to provide informed consent
  • pregnant women
  • and those undergoing emergent or urgent operative intervention at the time of diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer
new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma
Diagnostic test: TEG indices
Blood samples
Other Names:
  • Control
Control
Patients undergoing major surgery
Diagnostic test: TEG indices
Blood samples
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEG indices of coagulation
Time Frame: One Year
R time (minutes ~ coagulation factors), angle (degrees ~ fibrinogen function), MA (mm ~ platelets function), and LY30 (%~ fibrinolysis) measured at baseline (initial presentation or time of diagnosis), after neoadjuvant chemotherapy (if applicable), pre-operatively (before the induction of general anesthesia), intra-operatively (after tumor removal), post-operative days 1, 3 and 5, and at routine follow up appointments at 2 weeks, 3 months, 6 months and 1 year after surgery.
One Year
Disease burden as measured by TNM staging
Time Frame: One year
Disease burden as measured by TNM staging
One year
Pre- operative thrombotic and hemorrhagic complications.
Time Frame: One Year
Pre-operative thrombotic and hemorrhagic complications.
One Year
Recurrence free and overall survival.
Time Frame: One Year
Recurrence free and overall survival.
One Year
Proteomic analysis of intro-operative sample tumor microenvironment
Time Frame: One Year
Proteomic analysis of intro-operative sample tumor microenvironment
One Year
Post-operative thrombotic and hemorrhagic complications
Time Frame: One Year
Post-operative thrombotic and hemorrhagic complications
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Type
Time Frame: One Year
Benign, pre-malignant, malignant
One Year
Number of patients with pre-operative nodal
Time Frame: One Year
Benign, pre-malignant, malignant
One Year
Number of patients withneuronal invasion
Time Frame: One year
neuronal invasion
One year
Number of patients with mass resectability
Time Frame: One year
mass resectability
One year
Number of patients withcomplete pathologic resection
Time Frame: one year
complete pathologic resection
one year
Number of patients withsurgical margins
Time Frame: One year
surgical margins
One year
blood transfusion requirements
Time Frame: One Year
Number of patients withblood transfusion requirements
One Year
pre-operative distant metastasis
Time Frame: One year
Number of patients withpre-operative distant metastasis
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Haemonetics Corporation

Investigators

  • Principal Investigator: Ana Gleisner, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2022

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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