Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Phase 2

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: labetalol/hydralazine/enalapril

• Registration Number: NCT00963976
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2011-12
• Status Verified: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target systolic BP < 150 mmHg	labetalol/hydralazine/enalapril	Systolic blood pressure will be reduced to \<150 mmHg within 1 hour of randomization.
Target systolic BP < 180 mmHg	labetalol/hydralazine/enalapril	Systolic blood pressure will be reduced, to \<180 mmHg within 1 hour of randomization.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hematoma expansion rates at 24 hours.	24 hours post randomization

Trial Locations

Locations (4)

Grey Nuns Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada