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Comparing the cerebral pressure reactivity index after intensive and standard blood-pressure lowering in patients with hypertensive intracerebral hemorrhage: a one center, prospective, randomized, controlled, open-label clinical trial

Comparing the cerebral pressure reactivity index after intensive and standard blood-pressure lowering in patients with hypertensive intracerebral hemorrhage: a one center, prospective, randomized, controlled, open-label clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079064
Enrollment
Unknown
Registered
2023-12-25
Start date
2023-06-07
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertensive intracerebral hemorrhage

Interventions

Intensive blood-pressure lowering group (Group A):Lowering systolic blood-pressure to 110-139 mmHg
Standard blood-pressure lowering group (Group B):Lowering systolic blood-pressure to 140-170 mmHg

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: ? Patients agreed to participate and signed informed consent forms; ? Adult patients (range from 17 to 78 years old) with hypertensive intracerebral hemorrhage, who were admitted in 48 hours with systolic blood pressure >160mmHg; ? Patients with hypertensive intracerebral hemorrhage, who were underwent hematoma evacuation and ICP monitoring; ? Patients without postoperative hematoma expansion which demonstrated by CT scan; ? Patients with GCS 5-12.

Exclusion criteria

Exclusion criteria: ? Patients with traumatic brain injury, isolated intraventricular hemorrhage or systolic blood pressure <140mmHg; ? Patients with cerebrovascular diseases,such as aneurysm, vascular malformation, moyamoya disease, venous sinus thrombosis and so on; ? Patients with intracranial pathological changes including mental disorder, Parkinson's disease, cerebral infarction before hypertensive intracerebral hemorrhage; ? Patients with cerebellar hemorrhage, brain stem contusion, bilateral pupil dilation and GCS 3-4; ? Patients with known organ disorders, such as coronary heart disease, renal failure, liver dysfunction and need intervention by specialist; ? Patients taking anticoagulant therapies that could result in coagulopathies; ? Patients enrolled in other clinical trials in the last 30 days.

Design outcomes

Primary

MeasureTime frame
cerebral pressure reactivity index;

Secondary

MeasureTime frame
Mean ICP;Mean CPP;Optimal CPP;The proportion of mean CPP in optimal CPP;GOS score at 3 months;GOS score at 6 months;mRS at 3 months;mRS at 6 months;

Countries

China

Contacts

Public ContactFang Yuan

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

yf021025@126.com+86 189 3017 4964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026