Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Hypertension Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

labetalol/hydralazine/enalapril

Drug

Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).

Primary outcomes

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

Time frame: 2 hours post randomization

Secondary outcomes

Hematoma expansion rates at 24 hours.

Time frame: 24 hours post randomization

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

Alberta Heritage Foundation for Medical Research
Heart and Stroke Foundation of Canada

Registry information

Acronym: ICH ADAPT

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2012
First posted: Aug 24, 2009
Registry last updated: Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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