Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
Information source: University of Alberta
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intracerebral Hemorrhage
Intervention: labetalol/hydralazine/enalapril (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Alberta Overall contact:
Ken S Butcher, MD, PhD, FRCPC, Phone: 780 407 2171, Email: ken.butcher@ualberta.ca
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.
Clinical Details
Official title: Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
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)
Locations and Contacts
Ken S Butcher, MD, PhD, FRCPC, Phone: 780 407 2171, Email: ken.butcher@ualberta.ca
University of Alberta, Edmonton, Alberta T6G2B7, Canada; Recruiting
Ken S Butcher, MD PhD FRCPC, Phone: 780 407 2171, Email: ken.butcher@ualberta.ca
Ken S Butcher, MD PhD FRCPC, Principal Investigator
Grey Nuns Hospital, Edmonton, Alberta T6L 5X8, Canada; Not yet recruiting
Brian Buck, MD, Phone: 780 735 9626, Email: bbuck@ualberta.ca
Brian Buck, MD, FRCPC, Principal Investigator
University of Calgary, Calgary, Alberta, Canada; Recruiting
Andrew Demchuk, MD, FRCPC, Phone: 403 944 8671, Email: ademchuk@ucalgary.ca
Andrew Demchuk, MD, FRCPC, Principal Investigator
University of Ottawa, Ottawa, Ontario, Canada; Not yet recruiting
Dar Dowlatshahi, MD PhD FRCPC, Phone: 613 737 8899, Ext: 16449, Email: dowlatd@yahoo.com
Dar Dowlatshahi, MD PhD FRCPC, Principal Investigator
Additional Information
Starting date: January 2007
Ending date: November 2011
Last updated: September 29, 2009
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