The trial involved hospitals from nine low-income and middle-income countries and one high-income country, including Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, Vietnam, and Chile. Eligible hospitals were those without or with inconsistent disease-specific protocols, willing to implement the care bundle to consecutive patients aged 18 years or older with imaging-confirmed spontaneous intracerebral hemorrhage within 6 hours of symptom onset.
The care bundle protocol included early intensive lowering of systolic blood pressure, strict glucose control, antipyrexia treatment, and rapid reversal of warfarin-related anticoagulation. The primary outcome was functional recovery at 6 months, assessed using the modified Rankin scale.
A total of 121 hospitals enrolled 7,036 patients, with 3,221 assigned to the care bundle group and 3,815 to the usual care group. The results showed that the care bundle approach led to improved functional outcomes compared to usual care, with lower mortality rates, fewer serious adverse events, and enhanced quality of life. The effects of the care bundle were consistent across different subgroups.
The INTERACT3 trial has significant implications for the management of acute intracerebral hemorrhage. Hospitals are encouraged to incorporate the care bundle protocol into clinical practice to improve patient outcomes for this serious condition.
The trial was made possible through the joint funding support of the Joint Global Health Trials scheme from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, and the Medical Research Council and Wellcome Trust. Additional funding was provided by West China Hospital, the National Health and Medical Research Council of Australia, Sichuan Credit Pharmaceutic, and Takeda China.
The publication of the INTERACT3 trial results represents a significant advancement in the understanding and treatment of acute intracerebral hemorrhage. The findings will contribute to the ongoing efforts to improve patient care and outcomes for this debilitating condition.