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REperfusion With Cooling in CerebraL Acute IscheMia II (RECCLAIM-II)

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ClinicalTrials.gov Identifier: NCT02411877
Recruitment Status : Withdrawn (It was decided that it was not feasible to continue this study.)
First Posted : April 8, 2015
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
WellStar Health System

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Hypothermia Procedure: Normothermia Procedure: Mild hypothermia Device: Trevo Pro Retriever (Stryker Corp.) Device: Zoll Thermogard XP technology with the Quattro catheter Phase 2

Detailed Description:

This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention.

The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia:

  • Regulation of biomarkers indicative of ischemia-reperfusion injury
  • Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
  • Incidence of hemorrhagic conversion post reperfusion
  • Neurologic function at 90 days post acute ischemic stroke.

The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: REperfusion With Cooling in CerebraL Acute IscheMia II
Study Start Date : February 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Normothermia
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.)
Other Name: Clot retrieval, reperfusion

Device: Trevo Pro Retriever (Stryker Corp.)
Device: Trevo Pro Retriever (Stryker Corp.)

Experimental: Mild hypothermia
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: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
Other Name: Therapeutic hypothermia, clot retrieval, reperfusion

Device: Trevo Pro Retriever (Stryker Corp.)
Device: Trevo Pro Retriever (Stryker Corp.)

Device: Zoll Thermogard XP technology with the Quattro catheter
Device: Zoll Thermogard XP technology with the Quattro catheter




Primary Outcome Measures :
  1. Hemorrhagic Conversion [ Time Frame: 48 hours ]
    Acute bleeding into the area of the original stroke based on CT or MRI of the head.


Secondary Outcome Measures :
  1. Hyperintense Acute Reperfusion Marker (HARM) [ Time Frame: 48 +/- 24 hours ]
    HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.

  2. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days ]
    NIHSS is a scale from 1-42 to evaluate stroke severity

  3. Modified Rankin Scale (mRS) [ Time Frame: Basline, 48 +/- 24 hours, 90 +/- 15 days ]
    mRS is a straightforward evaluation of the functional limitations from stroke

  4. Number of participants with adverse events [ Time Frame: 90 days ]
    Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

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): NCT02411877


Locations
United States, Georgia
WellStar Kennestone Regional Medical Center
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
WellStar Health System
Zoll Medical Corporation
Investigators
Study Director: Rishi Gupta, MD WellStar Health System

Responsible Party: WellStar Health System
ClinicalTrials.gov Identifier: NCT02411877     History of Changes
Other Study ID Numbers: RECCLAIM II-S
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by WellStar Health System:
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

Additional relevant MeSH terms:
Ischemia
Hypothermia
Pathologic Processes
Body Temperature Changes
Signs and Symptoms