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 : August 2, 2021
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 ]modified Rankin Scale is a measure of physical function at 6 months, analyzed as an ordinal outcome (categories scored as 0 'no symptoms' to 5 as 'fully dependent, and 6 as death)
- Shift ('improvement') in survival and neurological impairment defined by scores on the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 7 days ]measure of physical function
- Death or disability defined by scores of 3-6 on the mRS [ Time Frame: 6 months ]measure of physical function
- Death [ Time Frame: 6 months ]measure of vital status
- Disability defined by scores 3-5 on the mRS [ Time Frame: 6 months ]measure of physical function
- Health-related quality of life (HRQoL) [ Time Frame: 6 months ]measure of quality of life on the EQ5D scale
- Duration of initial hospitalization [ Time Frame: 6 months ]measure of severity and service use
- Residence [ Time Frame: 6 months ]measure of 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 email@example.com|
|Contact: Lili Song, PhD||+86 10 firstname.lastname@example.org|
|West China Hospital||Recruiting|
|Chengdu, Sichuan, China|
|Contact: Lu Ma, PhD +86 18613228772 email@example.com|
|Principal Investigator:||Craig S Anderson, PhD||The George Institute for Global Health, China|
|Principal Investigator:||Chao You, PhD||West China Hospital|