Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Intracerebral Hemorrhage Clinical Trial

— ICH ADAPT  

Official title:

Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963976
• Other study ID #: ICHADAPT513000128
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2009
• Last updated: February 24, 2012
• Start date: January 2007
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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).

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Grey Nuns Hospital	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization.		2 hours post randomization	Yes
Secondary	Hematoma expansion rates at 24 hours.		24 hours post randomization	No