Spontaneous intracerebral hemorrhage: Recent advances and critical thinking on future clinical trial design

Abstract

[14–17] Medical therapies targeting hematoma expansion, such as the intensive lowering of systolic blood pressure (SBP) to less than 140 mmHg, reversal of anticoagulation or hemostatic therapy with Andexanet alfa, recombinant activated factor VII (rFVIIa), or tranexamic acid, showed a reduction of hematoma expansion without significant outcome benefit. [19] An ordinal analysis of modified Rankin Scale (mRS) scores indicated improved functional outcomes with intensive BP control. [27] An analysis of pooled data from all the RCTs registered in the Blood Pressure in Acute Stroke Collaboration showed that earlier SBP control to 120–140 mmHg over 24 h was associated with a significant lower risk of hematoma expansion and better functional outcomes, especially in patients with hematoma volume >10 mL. [18]A secondary analysis of the FAST data suggested that patients with age ≤70 years, ICH volume <60 mL, intraventricular hemorrhage (IVH) volume <5 mL, and onset-to-treatment time ≤2.5 h had almost 50% reduction in hematoma growth (7.3 ± 3.2 vs. 3.8 ± 1.5; P = 0.02) and a trend toward better functional outcome (adjusted OR, 0.28; 95% CI, 0.08–1.06).