REperfusion With Cooling in CerebraL Acute IscheMia II

NCT02411877 | Withdrawn Phase 2

• 1 other identifier: RECCLAIM II-S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether reducing a patient's body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients who 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 who have undergone hypothermia to those who have not.

Conditions

Ischemic Stroke; Hypothermia

Keywords

Acute ischemic stroke; Mild hypothermia; Stroke; Hypothermia; Cerebral infarction; Ischemia; Cerebrovascular disorder; Brain disease; Central nervous system disease; Nervous system disease; Vascular disease; Cardiovascular disease; Brain infarction; Brain ischemia; Pathologic process; Body temperature change; Signs and symptoms

Outcome Measures

Primary Outcomes (1)

• Hemorrhagic Conversion

  Acute bleeding into the area of the original stroke based on CT or MRI of the head.

  48 hours

Secondary Outcomes (4)

• Hyperintense Acute Reperfusion Marker (HARM)

  48 +/- 24 hours

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days

• Modified Rankin Scale (mRS)

  Basline, 48 +/- 24 hours, 90 +/- 15 days

• Number of participants with adverse events

  90 days

Study Arms (2)

Normothermia

ACTIVE COMPARATOR

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker), after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade.

Procedure: Normothermia; Device: Trevo Pro Retriever (Stryker Corp.)

Mild hypothermia

EXPERIMENTAL

As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker). Subjects will also have a catheter placed in the femoral vein (Zoll Thermogard XP technology with the Quattro catheter) 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.

Procedure: Mild hypothermia; Device: Trevo Pro Retriever (Stryker Corp.); Device: Zoll Thermogard XP technology with the Quattro catheter

Interventions

Normothermia PROCEDURE

Device: Trevo Pro Retriever (Stryker Corp.)

Also known as: Clot retrieval, reperfusion

Normothermia

Mild hypothermia PROCEDURE

Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)

Also known as: Therapeutic hypothermia, clot retrieval, reperfusion

Mild hypothermia

Trevo Pro Retriever (Stryker Corp.) DEVICE

Device: Trevo Pro Retriever (Stryker Corp.)

Mild hypothermia; Normothermia

Zoll Thermogard XP technology with the Quattro catheter DEVICE

Device: Zoll Thermogard XP technology with the Quattro catheter

Mild hypothermia

Eligibility Criteria

• Age: 18 Years - 79 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 \</= 79 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 CT imaging of the brain;
• 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, conscious sedation, 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;
• Baseline 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 or legally authorized representative 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) \>1.7 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;
• Prior neurologic event that would obscure interpretation of the signal and current presenting neurologic deficits;
• 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;

Sponsors & Collaborators

• WellStar Health System: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

WellStar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hypothermia; Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Pathologic Processes; Body Temperature Changes; Signs and Symptoms

Interventions

Reperfusion; Hypothermia, Induced

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Infarction; Necrosis

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Perfusion; Investigative Techniques; Cryotherapy; Therapeutics

Study Officials

• Rishi Gupta, MD

  WellStar Health System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

US (1)