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

February 16, 2016 updated by: WellStar Health System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.
Device: Trevo Pro Retriever (Stryker Corp.)
Device: Trevo Pro Retriever (Stryker Corp.)
Procedure: Mild hypothermia
Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
Other Names:
  • Therapeutic hypothermia, clot retrieval, reperfusion
Device: Zoll Thermogard XP technology with the Quattro catheter
Device: Zoll Thermogard XP technology with the Quattro catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemorrhagic Conversion
Time Frame: 48 hours
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
90 days
Hyperintense Acute Reperfusion Marker (HARM)
Time Frame: 48 +/- 24 hours
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
48 +/- 24 hours
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
Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
Modified Rankin Scale (mRS)
Time Frame: Basline, 48 +/- 24 hours, 90 +/- 15 days
mRS is a straightforward evaluation of the functional limitations from stroke
Basline, 48 +/- 24 hours, 90 +/- 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
WellStar Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zoll Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rishi Gupta, MD, Wellstar Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECCLAIM II-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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