Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03153683|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 18, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
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.
Collect standard of care clot and arterial blood during standard of care thrombectomy from Acute Ischemic Stroke Patients for lab analysis.
- 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
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
|Contact: Mary F Faulkner, BAfirstname.lastname@example.org|
|Contact: Justin F Fraser, MDemail@example.com|
|United States, Kentucky|
|University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital||Recruiting|
|Lexington, Kentucky, United States, 40536-0298|
|Principal Investigator:||Justin F Fraser, MD||University of Kentucky|