Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Condition(s) targeted: Intracerebral Hemorrhage

Intervention: labetalol/hydralazine/enalapril (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Alberta

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.

Official title: Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization.

Secondary outcome: Hematoma expansion rates at 24 hours.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

University of Calgary, Calgary, Alberta, Canada

Grey Nuns Hospital, Edmonton, Alberta T6L 5X8, Canada

University of Alberta, Edmonton, Alberta T6G2B7, Canada

University of Ottawa, Ottawa, Ontario, Canada

Starting date: January 2007
Last updated: February 24, 2012