Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracerebral Hemorrhage |
Drug: labetalol/hydralazine/enalapril |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial |
- 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 ] [ Designated as safety issue: Yes ]
- Hematoma expansion rates at 24 hours. [ Time Frame: 24 hours post randomization ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | January 2007 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Target systolic BP < 150 mmHg
Systolic blood pressure will be reduced to <150 mmHg within 1 hour of randomization.
|
Drug: labetalol/hydralazine/enalapril
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
|
|
Active Comparator: Target systolic BP < 180 mmHg
Systolic blood pressure will be reduced, to <180 mmHg within 1 hour of randomization.
|
Drug: labetalol/hydralazine/enalapril
Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G2B7 | |
| Grey Nuns Hospital | |
| Edmonton, Alberta, Canada, T6L 5X8 | |
| Canada, Ontario | |
| University of Ottawa | |
| Ottawa, Ontario, Canada | |
More Information
No publications provided by University of Alberta
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ken Butcher, Assistant Professor, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00963976 History of Changes |
| Other Study ID Numbers: | ICHADAPT513000128 |
| Study First Received: | August 21, 2009 |
| Last Updated: | February 24, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Stroke Hypertension Cerebral Blood Flow CT Perfusion |
Additional relevant MeSH terms:
|
Hemorrhage Cerebral Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Labetalol Enalapril Enalaprilat Hydralazine Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013