The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3)
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|ClinicalTrials.gov Identifier: NCT03209258|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 19, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8360 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Stepped-wedge Cluster Randomised Trial|
|Masking:||Single (Outcomes Assessor)|
|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|
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
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.
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.
- Shift ('improvement') in functional recovery (death or disability) defined by the modified Rankin Scale (mRS) [ Time Frame: 6 months ]
- Shift ('improvement') in survival and neurological impairment defined by scores on the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 7 days ]
- Death or disability defined by scores of 3-6 on the mRS [ Time Frame: 6 months ]
- Death [ Time Frame: 6 months ]
- Disability defined by scores 3-5 on the mRS [ Time Frame: 6 months ]
- Health-related quality of life (HRQoL) [ Time Frame: 6 months ]Measured by the EQ5D
- Duration of initial hospitalization [ Time Frame: 6 months ]
- Residence [ Time Frame: 6 months ]Patient living status (e.g. home, high care)
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
|Contact: Craig S Anderson, PhD||+86 10 82800577 ext firstname.lastname@example.org|
|Contact: Lili Song, PhD||+86 10 email@example.com|
|West China Hospital||Recruiting|
|Chengdu, Sichuang, China|
|Contact: Lu Ma, PhD +86 18613228772 firstname.lastname@example.org|
|Principal Investigator:||Craig S Anderson, PhD||The George Institute for Global Health, China|
|Principal Investigator:||Chao You, PhD||West China Hospital|