Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage
(ICH) remains controversial. Although it has been established that there is a transient
moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP
treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive
BP reduction.
Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of
acute BP reduction to < 150 mmHg systolic using a standardized protocol in ICH patients. It
is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following
acute BP reduction.
Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients
are randomized to a target systolic BP of < 150 mmHg or < 180 mmHg. Patients are treated with
intravenous (IV) labetalol/hydralazine/enalapril.
Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region,
measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the
difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma
expansion rates at 24 hours.
Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any
hemodynamic changes in the perihematoma region secondary to aggressive BP management. The
results of this trial will facilitate ongoing and future studies aimed at determining the
efficacy of rapid BP reduction in acute ICH.
Phase:
Phase 2
Details
Lead Sponsor:
University of Alberta
Collaborators:
Alberta Heritage Foundation for Medical Research Heart and Stroke Foundation of Canada