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Trials - SLCTR/2017/030

Protocol Change

Date

2025-06-23


Protocol

Protocol changed


Item Changed

Inclusion criteria


Previous Version

1. Male and female adults (>18 years) with a history of up to 6 months after symptom onset of primary ICH that is confirmed by imaging (copy of the brain imaging report to be submitted to the Central Coordinating Centre (CCC) labelled with study ID and with personal identifiers removed) 2. Clinically stable, as judged by investigator 3. Two resting systolic blood pressure (SBP) levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice) 4. Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up 5. Provision of written informed consent


Next Version

1. Adults (?18 years) with a history of primary ICH that is confirmed by imaging (copy of the brain imaging report to be uploaded to the database, labelled with participant identification [ID] and with personal identifiers removed) 2. Clinically stable, as judged by investigator 3. Average of two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in seated position (National Heart Foundation of Australia [NHF] Guidelines: Appendix 20.1). (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice) 4. Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up 5. No clear contraindication to any of the study treatments 6. Provision of written informed consent