Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study
NCT ID: NCT00526214
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-10-31
2009-08-31
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
In the control group, patients will not take the drug. We do not use placebo drugs.
No interventions assigned to this group
2
In the intervention group, patients will take celecoxib.
celecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
Interventions
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celecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Supratentorial location of hemorrhage
3. Older than 17 yrs
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jae-Kyu Roh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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References
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Chu K, Jeong SW, Jung KH, Han SY, Lee ST, Kim M, Roh JK. Celecoxib induces functional recovery after intracerebral hemorrhage with reduction of brain edema and perihematomal cell death. J Cereb Blood Flow Metab. 2004 Aug;24(8):926-33. doi: 10.1097/01.WCB.0000130866.25040.7D.
Other Identifiers
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12-2007-0084
Identifier Type: -
Identifier Source: secondary_id
H-0704-028-205
Identifier Type: -
Identifier Source: org_study_id
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