INTEnsive blood pressure Reduction in Acute Cerebral haemorrhage Trial

Completed

• Conditions: Intracerebral haemorrhage; Stroke - Haemorrhagic

• Registration Number: ACTRN12605000391673
• Lead Sponsor: The George Institute for International Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH) and elevated systolic BP (>150mmHg and <220mmHg), capacity to commence randomly assigned treatment with 6 hours of onset of ICH.

Exclusion Criteria

Clear indication for or contraindication for intensive BP lowering. Evidence ICH secondary to a structural abnormality, or use of thrombolytic agent, an ischemic stroke within 30 days, a score of 3-5 on the Galsgow Coma Scale (indicating a deep coma), significant pre-stroke disability or medical illness and planned early neurosurgical intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death[At 3 months];Dependency[At 3 months]

Secondary Outcome Measures

Name	Time	Method
All cause and cause specific early neurological deterioration[During the first 72 hours measured by reduction by 2 points in GCS or increase by 2 points in NIHSS from baseline.];Haematoma expansion during the first 72 hours[Measured by CT scans at 24 and 72 hours.];Cerebral oedema during the first 72 hours[Measured by CT scans at 24 and 72 hours. ];Functional disability[At Day 7, Day 28 and Day 90 using mRS and Barthel Index. ];Cognitive function[At Day 28 and Day 90 using MMSE ];Health Related Quality of Life[At Day 28 and Day 90 using EuroQuol5D ];Recurrent stroke[At Day 28 and Day 90];Acute myocardial infarction or sudden death from a cardiovascular cause.[At Day 28 and Day 90]