Brain, Blood And Clot or Tissue Registry And Collaboration (BACTRAC)

March 2, 2026 updated by: Justin Fraser

Brain, Blood And Clot or Tissue Registry And Collaboration (BACTRAC)

This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition.

The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.

This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky. Control participants will include patients undergoing non-emergent, elective diagnostic cerebral angiography as well as patients undergoing emergent angiogram cases.

This study represents the first time that tissue, clot and blood will be evaluated for the markers, proteins, and cytokines in human subjects undergoing cerebrovascular procedures.

By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation.

This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective open enrollment biorepository to collect and evaluate blood and tissue collected during cerebrovascular procedures, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in stroke and other cerebrovascular diseases in the human condition.

This research aims to advance understanding of cerebrovascular disease and to support the development of improved therapies.

The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.

Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for cerebrovascular procedures . Participants with impaired capacity may be included as the pathology to be studied may impair their capacity.

The primary endpoints of the study will be evaluation of specific proteins and leukocyte populations in the human stroke clot, tissues and blood.

The following describes all study procedures and evaluations that are to be done as part of the study.

Baseline:

  • Verify inclusion/exclusion criteria
  • Obtain consent from the patient or Legally Authorized Representative (LAR).
  • Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care)
  • Medication history (Standard of Care)
  • Baseline physical examination to include vital signs (Standard of Care)
  • Premorbid Modified Ranking Score (mRS)
  • NIH Stroke Scale (Standard of Care)
  • BMI (Standard of Care)
  • Cerebrovascular procedure (Standard of Care)
  • Study Specimen Collection

Data points recorded may include:

  • concomitant medications
  • the vessel location of the thrombus or disease
  • the time from Last Known Normal to vessel recanalization
  • the TICI score
  • the CTA collateral score at presentation
  • the baseline serum bicarbonate
  • the baseline O2 saturation
  • Medical history /co-morbid conditions

Study Specimen Collection

This protocol covers the procurement of tissue samples, blood samples, and other biological samples from patients undergoing any cerebrovascular surgery and/or clinical procedure.

Any tissue or biological sample that is procured as part of a normal cerebrovascular procedures and which would otherwise be discarded can be collected under this protocol. Examples of these tissue samples include:

  • Blood vessels (arterial or venous)
  • Brain tissue
  • Thrombus tissue
  • AVM nidus from resection
  • AVF nidus from resection
  • Aneurysms if resected
  • Carotid stenosis plaques from CEA

Peripheral blood samples may also be collected from patients. These are the only biospecimens that will be procured specifically for this research and that are not collected as part of normal cardiac care. These samples will consist of 5 to 10 cc of peripheral blood and may be collected:

  • Prior to procedure
  • Immediately after procedure
  • At different time intervals after the procedure during the hospital stay. These samples will not exceed the frequency and volume limits detailed in the IRB regulations
  • At the outpatient follow-up after procedure
  • Annually at an office-visit
  • Upon readmission if hospitalized

Study Type

Observational

Enrollment (Estimated)

1000

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

  • Name: Justin F Fraser, MD
  • Phone Number: 859-323-0616
  • Email: jfr235@uky.edu

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • Recruiting
        • University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include up to 1000 subjects with cerebrovascular disease or suspected cerebrovascular disease. Male and female participants 18 years of age and older will be enrolled.

This protocol covers the procurement of biological samples from patients undergoing any cerebrovascular surgery and/or neurointerventional clinical procedure at University of Kentucky.

Description

Inclusion Criteria 1. All patients, Male or female, aged 18 years or older, undergoing cerebrovascular surgery/procedure at the University of Kentucky.

Exclusion Criteria:

1. Pregnant or breastfeeding females

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
Cerebrovascular procedure patients
This is a registry. No above standard of care interventions will take place. Participants must be undergoing a clinically routine cerebrovascular procedure.
Other: Registry
Collect standard of care clot, tissue and arterial blood during standard of care cerebrovascular procedure for lab analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate pH of blood as a marker of acid/base balance in distal blood and proximal blood, and correlate to interval of time between Last Known Normal and vessel recanalization.
Time Frame: Assessed over the course of the study, an estimated 3 years.
A small amount of blood (from the two specimens) will be sent for blood gas analysis to evaluate the pH, pO2, pCO2, pHCO3 potassium, sodium, and calcium concentrations.
Assessed over the course of the study, an estimated 3 years.

Collaborators and Investigators

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

Sponsor

Justin Fraser

Collaborators

University of Kentucky

Investigators

  • Principal Investigator: Justin F Fraser, MD, University Of Kentucky

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 (Actual)

May 11, 2017

Primary Completion (Estimated)

December 28, 2029

Study Completion (Estimated)

December 28, 2029

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BACTRAC-17-0019-F1V

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be announced.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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