Intracerebral Hemorrhage
Conditions
Keywords
Spontaneous intracerebral hemorrhage, Acute Spontaneous, Supratentorial intracerebral hemorrhage
Brief summary
Primary: Change of volume of perihematomal edema as assessed by brain CT. Secondary: The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study
Detailed description
1. INCLUSION/EXCLUSION CRITERIA 1. Inclusion Criteria * Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms * Supratentorial location of hemorrhage * Older than 17 yrs * Informed consent before study 2. Exclusion Criteria * Planned surgical evacuation of hematoma within 24hrs * Secondary ICH such as trauma or aneurysmal rupture * Taking anticoagulation previously * Pregnancy,known allergy to celecoxib, severe liver or kidney disease, or poor performance state were excluded * Other physical condition, making the patient difficult to participate in this study (decided by the neurologist or the physician). 2. OTHER THERAPY -No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms 3. STUDY DESIGN Multicenter, prospective randomized, comparative open with blinded endpoints (PROBE) trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage
Interventions
DRUGcelecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms 2. Supratentorial location of hemorrhage 3. Older than 17 yrs
Exclusion criteria
1. Planned surgical evacuation of hematoma within 24hrs 2. Secondary ICH due to trauma or aneurismal rupture or etc 3. Taking antithrombotics or other NSAIDs previously 4. Pregnancy 5. Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of volume of perihematomal edema as assessed by brain CT | at 1st day of admission and repeated at 7th±1 day | Brain CT scanning for measurement of volumes of ICH and perihematomal edema was performed at 1st day of admission and repeated at 7th±1 day. Considering some possible errors in measurement of edema volume, at follow-up CT scan, the decrease more than 20% from the initial edema volume was coded as decreased edema volume; the increase more than 20% was coded as increased; the change between -20% and 20% was coded as unchanged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The neurological status at 90 day using E-GOS and mRS | 90 days after onset. | The secondary endpoints were neurological status at 90 day using E-GOS and mRS. Good outcome was defined as 6 or more in E-GOS score, and 2 or less in mRS score. |
| Change of ICH volume between the initial and the follow-up CT scans | Day1, Day 7 | Change of ICH volume between the initial and the follow-up CT scans. In this analysis, the 20% criterion was applied as mentioned in the edema analysis |
| Major and minor adverse events | anytime for 3 months | the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study |
Countries
South Korea
Outcome results
None listed