The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage 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.

Conditions

• Cerebral Hemorrhage
• Stroke
• Hypertension
• Diabetes
• Anticoagulant-induced Bleeding
• Cerebral Vascular Disorder
• Brain Disorder
• Hemorrhage
• Intracranial Hemorrhages
• Cardiovascular Diseases
• Central Nervous System Diseases

Interventions

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

Usual care

Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• Sichuan Credit Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Takeda

  collaborator INDUSTRY

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Department for International Development, United Kingdom

  collaborator OTHER_GOV

• UK Research and Innovation

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• The George Institute for Global Health, China

  lead OTHER

Principal Investigators

• Craig S Anderson, PhD · The George Institute for Global Health, China

• Chao You, PhD · West China Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-12

Primary Completion

2022-10-12

Completion

2022-11-17

Countries

• China

Study Locations