Efficacy of morphine as an adjuvant therapy to early anti-hypertensive drugs in intra-cerebral hemorrhage patients

Phase 2

Recruiting

Conditions: intracerebral hemorrhage.
Nontraumatic intracerebral hemorrhage

Registration Number: IRCT20210530051440N2

Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

Acute stroke syndrome due to spontaneous ICH, which is defined as the sudden occurrence of bleeding into the parenchyma of the brain that may extend into the ventricles or subarachnoid space as confirmed by a clinical history and computed tomography (CT) scan
Systolic BP =?150 mmHg at least twice (based on brachial artery pressure measured in the upper arm in two measurements conducted =?2 min apart)
Age?>?18 years
Feasible for emergency antihypertensive treatment and real-time BP monitoring
Symptom onset within 24 h (if the time of onset is unknown, the last known time is selected)
Special care unit (SCU) or stroke unit admission within 24 h

Exclusion Criteria

Subjects with contraindications for emergency-intensified antihypertensive treatment (such as severe carotid, vertebral or cerebral artery stenosis, known Moyamoya disease or multiple arteritis, and severe aortic stenosis or severe kidney failure)
Intracranial hemorrhage secondary to intracranial tumor, recent trauma, cerebral infarction and thrombolytic therapy
History of ischemic stroke within 30 days before disease onset
The presence of dementia (previously diagnosed by a medical institution) or significant post-stroke disability (modified Rankin Scale (mRS) =?3 points [32])
pregnancy or lactating

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure control. Timepoint: Blood pressure will be controlled every 15 minutes for 2 hours at the start of treatment, then every 30 minutes for 6 hours, then every 1 hour for 16 hours, and then every 6 hours for a week. Method of measurement: Physical examination.;National Institutes of Health Stroke Scale (NIHSS) score. Timepoint: At Admission, 24 hours later and at discharge. Method of measurement: Physical Examination.;Modified Rankin Scale (MRS) score. Timepoint: At admission and 3 months after discharge. Method of measurement: Questionnaire.;Mortality. Timepoint: In-hospital and during 3 months after discharge. Method of measurement: Medical records and follow up information.

Secondary Outcome Measures