Intracerebral Hemorrhage
Conditions
Keywords
Stroke, Hypertension, Cerebral Blood Flow, CT Perfusion
Brief summary
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.
Interventions
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
Sponsors
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Acute primary ICH demonstrated with CT scan * Onset ≤ 24 h prior to randomization
Exclusion criteria
* Contraindication to BP reduction i.e., severe arterial stenosis or high-grade stenotic valvular heart disease * Indication for urgent BP reduction i.e., hypertensive encephalopathy, or aortic dissection * Definite evidence that the ICH is secondary to underlying cerebral or vascular pathology, i.e., AVM, aneurysm, tumour, trauma, vasculitis, or hemorrhagic transformation of an ischemic infarct * Previous ischemic stroke within 30 days of current event NB: Prior ICH is not an exclusion criterion * Planned surgical resection of hematoma NB: Extraventricular Drain placement is not an exclusion criterion * Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. | 2 hours post randomization |
Secondary
| Measure | Time frame |
|---|---|
| Hematoma expansion rates at 24 hours. | 24 hours post randomization |
Countries
Canada
Outcome results
None listed