Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study

Study Overview
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Brief Summary
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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
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INCLUSION/EXCLUSION CRITERIA 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 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). OTHER THERAPY -No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms 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

Official Title
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Multi-center, Prospective Randomized, Comparative Open With Blinded Endpoints (PROBE) Trial to Assess the Safety and Effectiveness of Administration of Celecoxib in Patients With Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: celecoxib medication


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Planned surgical evacuation of hematoma within 24hrs Secondary ICH due to trauma or aneurismal rupture or etc Taking antithrombotics or other NSAIDs previously Pregnancy Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>In the control group, patients will not take the drug. We do not use placebo drugs. | |
| Experimental: 2<br>In the intervention group, patients will take celecoxib. | Drug: celecoxib medication<br>* In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.<br>* Other names: celecoxib(celebrex);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of volume of perihematomal edema as assessed by brain CT | 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. | at 1st day of admission and repeated at 7th±1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The neurological status at 90 day using E-GOS and mRS | 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. | 90 days after onset. | 
| Change of ICH volume between the initial and the follow-up CT scans | 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 | Day1, Day 7 | 
| Major and minor adverse events | the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study | anytime for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spontaneous intracerebral hemorrhage, Acute Spontaneous, Supratentorial intracerebral hemorrhage