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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209258
Other study ID # ICH-WCH&GI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2017
Est. completion date November 17, 2022

Study information

Verified date November 2022
Source The George Institute for Global Health, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Care bundle of active management
Intensive BP lowering to systolic target of <140mmHg; Glucose control target 6.1-7.8 mmol/l for non-diabetic; 7.8-10.0 mmol/l for diabetic patients; Treatment of pyrexia to a target body temperature =37.5 ?; 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.
Usual care
Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Locations

Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (8)

Lead Sponsor Collaborator
The George Institute for Global Health, China Department for International Development, United Kingdom, Medical Research Council, National Institute for Health Research, United Kingdom, SICHUAN CREDIT PHARMACEUTICAL CO., LTD., Takeda, UK Research and Innovation, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shift ('improvement') in functional recovery (death or disability) defined by the modified Rankin Scale (mRS) 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) 6 months
Secondary Shift ('improvement') in survival and neurological impairment defined by scores on the National Institutes of Health Stroke Scale (NIHSS) measure of physical function 7 days
Secondary Death or disability defined by scores of 3-6 on the mRS measure of physical function 6 months
Secondary Death measure of vital status 6 months
Secondary Disability defined by scores 3-5 on the mRS measure of physical function 6 months
Secondary Health-related quality of life (HRQoL) measure of quality of life on the EQ5D scale 6 months
Secondary Duration of initial hospitalization measure of severity and service use 6 months
Secondary Residence measure of patient living status (e.g. home, high care) 6 months
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