Reperfusion With Cooling in Cerebral Acute Ischemia II

NCT01728649 | Withdrawn DMC

• 1 other identifier: MSNC 02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients that have undergone hypothermia to those that have not.

Conditions

Ischemic Stroke; Hypothermia

Keywords

Acute Ischemic Stroke; Mild Hypothermia; Stroke; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.

  90 days

Secondary Outcomes (5)

• Hyperintense Acute Reperfusion Marker (HARM)

  48+/- 24 hours

• Hemorrhagic Conversion

  48hrs

• National Institutes of Health Stroke Scale (NIHSS)

  90 days

• Modified Rankin Scale (mRS)

  90 days

• Biomarkers

  Before therapy then immediately after, 8hrs, and 24hrs after reperfusion

Study Arms (2)

Normothermia

NO INTERVENTION

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices. After which patient will be started on normothermia attempting to keep core body temp between 38 and 36.5 degrees centigrade. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.

Mild Hypothermia

EXPERIMENTAL

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared device. Patient will also have a Quattro catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours and then be rewarmed very slowly. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.

Other: Mild Hypothermia

Interventions

Mild Hypothermia OTHER

Hypothermia will be achieved using the Zoll Thermoguard XP technology with the Quattro catheter. This catheter has a 9.3 Fr diameter and is 4 3cm long. It will be placed in the patients femoral vein via Seldinger technique, before reperfusion is achieved. Hypothermia will be initiated prior to reperfusion. Once temperature has reached 33.5 degrees centigrade the patient will remain at that temperature for 12 hours after which the patient will undergo active gradual rewarming at 0.2 degrees centigrade per hour.

Also known as: Hypothermia, Therapeutic Hypothermia

Mild Hypothermia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects of any ethnicity and age \>/=18 but \</= 85 years;
• Symptom onset \</=8 hours;
• Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI;
• Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
• Ability to undergo endovascular reperfusion therapy;
• No contraindications to general anesthesia or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
• A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
• Arterial puncture performed under 8 hours from symptom onset or last seen normal
• Baseline MRI or CT scan shows no hemorrhage;
• National Institutes of Health Stroke Scale (NIHSS) 14-29;
• Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
• Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
• Subject must be able to understand and give written informed consent.

You may not qualify if:

• Females of childbearing potential who are pregnant or not using adequate contraception;
• Bleeding diathesis with a platelet count \< 50,000 or International Normalized Ratio (INR) \>1.5 or any active or recent (within 10 to 30 days) hemorrhage;
• History of genetically confirmed hypercoagulable syndrome;
• Any condition that excludes MRI imaging;
• History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms;
• End stage renal disease on hemodialysis;
• History of cardiac arrest;
• Presence of an inferior vena cava (IVC) filter;
• Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
• Known allergy to meperidine or buspar;
• Sustained hypertension (systolic blood pressure (SBP) \> 185 or diastolic blood pressure (DBP) \> 110 refractory to treatment);
• Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
• Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
• Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
• Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study

Sponsors & Collaborators

• WellStar Health System: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hypothermia; Stroke

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Christopher Horn, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Rishi Gupta, MD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Neurosurgery

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: November 20, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

US (1)