The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

April 21, 2023 updated by: The University of Texas Medical Branch, Galveston
The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB.

Description

Inclusion Criteria:

  1. Colorectal cancer requiring surgical intervention-elective

    a)Benign or Malignant

  2. Inflammatory colorectal conditions requiring surgical intervention-elective

    1. Diverticulitis
    2. Ulcerative Colitis
    3. Crohn's Disease

Exclusion Criteria:

  • Pregnancy
  • Emergency procedures

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
UTMB's Colorectal Surgical Cohort
Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB
Diagnostic test: D-dimer and lower limb venous duplex
D-dimer blood test- The D-dimer assay detects the presence of fibrin degradation products, which can indicate the breakdown of a fibrin clot Lower Limb Venous Duplex- Using an ultrasound to visually look for a clot

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observe the point prevalence of DVT's in preoperative colorectal patients at UTMB prior to having colorectal surgery.
Time Frame: 1 year
The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.
1 year
Determine the incidence of postoperative DVT that occurred during the first 2 days of the inpatient stay that was discovered by a lower limb venous duplex
Time Frame: 1 year
Subjects will have a venous duplex on day two after surgery to look for a DVT
1 year
Compare the number of DVT events in postoperative hospitalized patients that were on the D-dimer monitoring protocol.
Time Frame: 1 year
The data will be used to determine the number of DVT's that were discovered in the subject population and to establish baseline rates of DVT after surgery and hospital discharge
1 year
Determine if there is a statistical difference between the D-dimer value of patients with DVT prior to surgery compared to patients who develop DVT after surgery
Time Frame: 1 year
This data will be used to compare the D-dimer values in subjects that had DVT prior to surgery to those who developed a postoperative DVT while inpatient or at the postoperative clinic appointment
1 year
Compare the D-dimer results of DVT positive subjects to DVT negative subjects to identify a specific result range seen in the DVT positive subjects.
Time Frame: 1 year
These results will be used as preliminary evidence for future research to determine if revised D-dimer cut off values can be diagnostic in conditions known to have low test specificity
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uma Phatak, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-0266

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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