Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)

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ClinicalTrials.gov Identifier: NCT00963976

Recruitment Status : Completed

First Posted : August 24, 2009

Last Update Posted : February 28, 2012

Sponsor:

Collaborators:

Heart and Stroke Foundation of Canada

Alberta Heritage Foundation for Medical Research

Information provided by (Responsible Party):

Ken Butcher, University of Alberta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage	Drug: labetalol/hydralazine/enalapril	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
Study Start Date :	January 2007
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	February 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding

Drug Information available for: Hydralazine Hydralazine hydrochloride Labetalol Enalapril Enalapril maleate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

Hematoma expansion rates at 24 hours. [ Time Frame: 24 hours post randomization ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963976

Locations

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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

Sponsors and Collaborators

University of Alberta

Heart and Stroke Foundation of Canada

Alberta Heritage Foundation for Medical Research

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Klahr AC, Kosior JC, Dowlatshahi D, Buck BH, Beaulieu C, Gioia LC, Kalashyan H, Wilman AH, Jeerakathil T, Emery DJ, Shuaib A, Butcher KS. Lower Blood Pressure Is Not Associated With Decreased Arterial Spin Labeling Estimates of Perfusion in Intracerebral Hemorrhage. J Am Heart Assoc. 2019 Jun 4;8(11):e010904. doi: 10.1161/JAHA.118.010904.

McCourt R, Gould B, Kate M, Asdaghi N, Kosior JC, Coutts S, Hill MD, Demchuk A, Jeerakathil T, Emery D, Butcher KS. Blood-brain barrier compromise does not predict perihematoma edema growth in intracerebral hemorrhage. Stroke. 2015 Apr;46(4):954-60. doi: 10.1161/STROKEAHA.114.007544. Epub 2015 Feb 19.

Gould B, McCourt R, Gioia LC, Kate M, Hill MD, Asdaghi N, Dowlatshahi D, Jeerakathil T, Coutts SB, Demchuk AM, Emery D, Shuaib A, Butcher K; ICH ADAPT Investigators. Acute blood pressure reduction in patients with intracerebral hemorrhage does not result in borderzone region hypoperfusion. Stroke. 2014 Oct;45(10):2894-9. doi: 10.1161/STROKEAHA.114.005614. Epub 2014 Aug 21.

McCourt R, Gould B, Gioia L, Kate M, Coutts SB, Dowlatshahi D, Asdaghi N, Jeerakathil T, Hill MD, Demchuk AM, Buck B, Emery D, Butcher K; ICH ADAPT Investigators. Cerebral perfusion and blood pressure do not affect perihematoma edema growth in acute intracerebral hemorrhage. Stroke. 2014 May;45(5):1292-8. doi: 10.1161/STROKEAHA.113.003194. Epub 2014 Apr 1.

Butcher KS, Jeerakathil T, Hill M, Demchuk AM, Dowlatshahi D, Coutts SB, Gould B, McCourt R, Asdaghi N, Findlay JM, Emery D, Shuaib A; ICH ADAPT Investigators. The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial. Stroke. 2013 Mar;44(3):620-6. doi: 10.1161/STROKEAHA.111.000188. Epub 2013 Feb 7.

Butcher K, Jeerakathil T, Emery D, Dowlatshahi D, Hill MD, Sharma M, Buck B, Findlay M, Lee TY, Demchuk AM. The Intracerebral Haemorrhage Acutely Decreasing Arterial Pressure Trial: ICH ADAPT. Int J Stroke. 2010 Jun;5(3):227-33. doi: 10.1111/j.1747-4949.2010.00431.x.

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Responsible Party:	Ken Butcher, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier:	NCT00963976
Other Study ID Numbers:	ICHADAPT513000128
First Posted:	August 24, 2009 Key Record Dates
Last Update Posted:	February 28, 2012
Last Verified:	February 2012

Keywords provided by Ken Butcher, University of Alberta:


Stroke Hypertension Cerebral Blood Flow CT Perfusion

Additional relevant MeSH terms:

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Cerebral Hemorrhage Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Enalapril Hydralazine Labetalol Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Vasodilator Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists

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