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Merits of Early Blood Pressure Control for ICH Stroke Confirmed by INTERACT3 Trial Findings
A swift reduction of systolic blood pressure, along with several other interventions referred to as a “Care Bundle,” significantly increases the chances of survival without significant impairment in intracerebral hemorrhage (ICH) stroke patients. Findings from the phase III INTERACT3 trial were published in The Lancet.
"In spite of the elevated prevalence and gravity of ICH, the available treatment options are limited. However, early management of high blood pressure holds the greatest promise,” said Craig Anderson, PhD, director, Global Brain Health, The George Institute for Global Health, Australia. “Given the time-sensitive nature of treating this form of stroke, we conducted a trial that combined interventions aimed at swiftly stabilizing the patients' condition to enhance their prognosis. We project that if this protocol were universally implemented, it has the potential to save tens of thousands of lives annually worldwide."
The George Institute for Global Health research team aimed to determine whether an innovative treatment amalgamation, known as the Care Bundle, would improve ICH patient outcomes in a hospital setting. The Care Bundle, ideally administered within 1 hour of treatment, included early and intensive reduction of systolic blood pressure (target <140 mm Hg), close control of glucose levels (target 6.1-7.8 mmol/L without diabetes, 7.8-10.0 mmol/L with diabetes), targeted management of fever (target less than or equal to 99.5° F), and quick correction of abnormal anticoagulation (target international normalized ratio <1.5). The “pragmatic, international, multicenter, blinded endpoint, stepped wedge cluster randomized controlled trial” included hospitals in 9 low- and middle-income, and 1 high-income country, encompassing 144 hospitals and over 7,000 patients.
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Researchers evaluated outcomes according to a modified intention-to-treat population with available outcome data. The primary outcome was functional recovery assessed through the modified Rankin scale (mRS; range 0 [no symptoms] to 6 [death]) at 6 months by masked research staff, analyzed using proportional ordinal logistic regression to examine mRS score distribution with adjustments for cluster (hospital site), group assignment of cluster per period, and time.
Of the 7036 patients included, 3221 were assigned to the care bundle group and 3815 were assigned to the usual care group. Primary outcome data was available for 2892 patients in the care bundle group, and 3815 in the usual care group. Likelihood of a poor functional outcome was lower in the care bundle group than the usual care group (common odds ratio 0.86; 95% CI 0.76-0.97; p=0.015). The care bundle group also exhibited favorable mRS scores (0.84; 0.73-0.97; p=0.017) and had fewer serious adverse effects (16.0% vs 20.1%; p=0.0098).
“In summary, the findings of our trial provide evidence to support the adoption of an active protocol for intensive blood pressure lowering and the associated management of key abnormal physiological variables within several hours after the onset of signs to improve the recovery of patients presenting with acute intracerebral hemorrhage,” the authors concluded in the study discussion.
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