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Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC)

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ClinicalTrials.gov Identifier: NCT03153683
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Justin Fraser, University of Kentucky

Brief Summary:

This is a prospective open enrollment registry to evaluate arterial blood and thrombus removed during the standard thrombectomy procedure, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in large vessel occlusive stroke in the human condition. The primary objectives are to evaluate the feasibility of obtaining distal clot blood during thrombectomy; develop a group of biosamples (blood and clots) to evaluate novel proteins, cell types, and cytokines in acute ischemic stroke in the human condition, and evaluate specific biomarkers, proteins, and leukocyte populations in stroke in the human condition. The study population will include up to 250 subjects. Male and female participants 18 years of age and older will be enrolled. Participants must have had a suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky. There is no therapeutic intervention involved in this study.

This is the first study to our knowledge that will utilize thrombectomy technique to collect focal blood samples and the clot related brain infarction. This proposal will provide preliminary data needed to understand relationships between the local inflammatory cascade and clinical variables such as age, gender, time from symptoms to thrombectomy, and stroke imaging results. Characterizing these relationships is vital in the formulation of related therapeutics. Issues of gender-differences, age-based variations, and co-morbidities all engender heterogeneity, which plague translation of stroke research from animal to human. 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.


Condition or disease Intervention/treatment
Acute Ischemic Stroke Other: Registry

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC)
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Group/Cohort Intervention/treatment
Acute Ischemic Stroke Patients
This is a registry. No above standard of care interventions will take place. Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy per standard of care.
Other: Registry
Collect standard of care clot and arterial blood during standard of care thrombectomy from Acute Ischemic Stroke Patients for lab analysis.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
1 cc of arterial distal blood, thrombus, and 5 cc of peripheral arterial blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population will include up to 250 subjects. Male and female participants 18 years of age and older will be enrolled. Participants must have had a suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
Criteria

Inclusion Criteria:

  1. Patient or the Legally Authorized Representative (LAR) as recognized by the State of Kentucky will be consented for the study within 24 hours post procedure.
  2. Male or female, aged 18 years or older.
  3. Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
  4. Participants must meet criteria for intra-arterial thrombectomy as determined and documented by Interventional Radiology attending physician at University of Kentucky.
  5. Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy.
  6. Participants with impaired capacity may be included as the pathology to be studied (stroke) may impair their capacity.
  7. Participant must undergo thrombectomy procedure.
  8. For females of reproductive potential: Negative urine pregnancy test at baseline.

Exclusion Criteria:

  • There are no specific exclusion criteria outside of meeting the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153683


Contacts
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Contact: Mary F Faulkner, BA 859-218-5006 mffaul2@uky.edu
Contact: Justin F Fraser, MD 859-323-0616 jfr235@uky.edu

Locations
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United States, Kentucky
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital Recruiting
Lexington, Kentucky, United States, 40536-0298
Sponsors and Collaborators
Justin Fraser
University of Kentucky
Investigators
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Principal Investigator: Justin F Fraser, MD University of Kentucky
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Justin Fraser, Asst Professor of Cerebrovascular, Endovascular, & Skull Base Surgery; Director, Cerebrovascular Surgery; Depts of Neurological Surgery, Neurology, Radiology, and Anatomy & Neurobiology; Center for Advanced Translational Stroke Science; Univ of KY, University of Kentucky
ClinicalTrials.gov Identifier: NCT03153683    
Other Study ID Numbers: BACTRAC-17-0019-F1V
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be announced.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Justin Fraser, University of Kentucky:
Acute
Ischemic
Stroke
Biomarkers
Proteins
Leukocyte
Inflammatory Cells
Acid/Base Balance
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes