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The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3)

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: NCT03209258
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
West China Hospital
SICHUAN CREDIT PHARMACEUTICAL CO., LTD.
Takeda
Information provided by (Responsible Party):
Craig Anderson, The George Institute for Global Health, China

Brief Summary:

Continued uncertainty exists over benefits of early intensive blood pressure (BP) lowering in acute intracerebral hemorrhage (ICH), related to the non-significant primary outcomes, patient selection, and discordant results of INTERACT2 and ATACH-II. We designed INTERACT3 to determine the effectiveness of a goal-directed care bundle of active management (intensive BP lowering, glycemic control, treatment of pyrexia and reversal of anticoagulation) vs. usual care in ICH.

INTERACT3 is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute ICH.


Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Stroke Hypertension Diabetes Anticoagulant-induced Bleeding Cerebral Vascular Disorder Brain Disorder Hemorrhage Intracranial Hemorrhages Cardiovascular Diseases Central Nervous System Diseases Other: Care bundle of active management Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8360 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped-wedge Cluster Randomised Trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigator Initiated and Conducted, International, Multicenter, Stepped Wedge Cluster Randomized Study of a Care Bundle of Physiological Control Strategies in Acute Intracerebral Hemorrhage
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Goal-directed care bundle
Management policy to receive a goal-directed care bundle that involves the rapid correction (<1 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 7 days or hospital discharge (or death, if sooner)
Other: Care bundle of active management
  1. Intensive BP lowering to systolic target of <140mmHg;
  2. Glucose control target 6.1-7.8 mmol/l for non-diabetic; 7.8-10.0 mmol/l for diabetic patients;
  3. Treatment of pyrexia to a target body temperature ≤37.5 ℃;
  4. Reversal of anticoagulation to target INR <1.5 involving use of vitamin K and prothrombin complex concentrate (PCC) or alternatively, fresh frozen plasma (FFP).

As the trial is an assessment of care bundle of physiological management, there is some flexibility in the use of particular BP lowering agents and antipyretic agents to achieve targets.

Other Names:
  • Early intensive BP lowing
  • Intensive glucose control
  • Early treatment of pyrexia
  • Reversal of anticoagulation

Usual care group
Patients receive the usual management based on local guidelines and hospital's individual policy.
Other: Usual care
Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.




Primary Outcome Measures :
  1. Shift ('improvement') in functional recovery (death or disability) defined by the modified Rankin Scale (mRS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Shift ('improvement') in survival and neurological impairment defined by scores on the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 7 days ]
  2. Death or disability defined by scores of 3-6 on the mRS [ Time Frame: 6 months ]
  3. Death [ Time Frame: 6 months ]
  4. Disability defined by scores 3-5 on the mRS [ Time Frame: 6 months ]
  5. Health-related quality of life (HRQoL) [ Time Frame: 6 months ]
    Measured by the EQ5D

  6. Duration of initial hospitalization [ Time Frame: 6 months ]
  7. Residence [ Time Frame: 6 months ]
    Patient living status (e.g. home, high care)



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

Inclusion Criteria:

  • Aged ≥18 years
  • Acute stroke syndrome that is due to presumed spontaneous ICH, confirmed by clinical history and a CT scan within 6 hours of stroke onset without/without contrast, and if an CT angiogram is also undertaken as part of routine care.
  • Presentation to hospital within 6 hours of stroke onset.

Exclusion Criteria:

  • Definite evidence that the ICH is secondary to a structural abnormality in the brain (eg an AVM, intracranial aneurysm, tumour, trauma, or previous cerebral infarction) or previous thrombolysis.
  • A high likelihood that the patient will not adhere to the study treatment and follow-up regimen. In each case, the decision about the patient's eligibility will be based on the attending clinician's interpretation of the above eligibility criteria.

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): NCT03209258


Contacts
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Contact: Craig S Anderson, PhD +86 10 82800577 ext 557 canderson@georgeinstitute.org.cn
Contact: Lili Song, PhD +86 10 82800577 lsong@georgeinstitute.org.cn

Locations
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China, Sichuang
West China Hospital Recruiting
Chengdu, Sichuang, China
Contact: Lu Ma, PhD    +86 18613228772    alex80350305@163.com   
Sponsors and Collaborators
The George Institute for Global Health, China
West China Hospital
SICHUAN CREDIT PHARMACEUTICAL CO., LTD.
Takeda
Investigators
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Principal Investigator: Craig S Anderson, PhD The George Institute for Global Health, China
Principal Investigator: Chao You, PhD West China Hospital
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Responsible Party: Craig Anderson, Executive Director, The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT03209258    
Other Study ID Numbers: ICH-WCH&GI
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Craig Anderson, The George Institute for Global Health, China:
Stroke
Intracerebral Hemorrhage
Care Bundle
Clinical Trial
Stepped-wedge Cluster
Management
Blood Pressure
Additional relevant MeSH terms:
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Nervous System Diseases
Cerebral Hemorrhage
Central Nervous System Diseases
Intracranial Hemorrhages
Brain Diseases
Cerebrovascular Disorders
Cardiovascular Diseases
Vascular Diseases
Disease
Hemorrhage
Pathologic Processes