Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study (ACE-ICH)
Change of volume of perihematomal edema as assessed by brain CT.
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Change of volume of perihematomal edema as assessed by brain CT [ Time Frame: at 1st day of admission and repeated at 7th±1 day ] [ Designated as safety issue: No ]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".
- The neurological status at 90 day using E-GOS and mRS [ Time Frame: 90 days after onset. ] [ Designated as safety issue: No ]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 [ Time Frame: Day1, Day 7 ] [ Designated as safety issue: No ]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 [ Time Frame: anytime for 3 months ] [ Designated as safety issue: Yes ]the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study
|Study Start Date:||October 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
No Intervention: 1
In the control group, patients will not take the drug. We do not use placebo drugs.
Drug: celecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
Other Name: celecoxib(celebrex)
- 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
- 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).
-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
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Jae-Kyu Roh, MD, PhD||Seoul National University Hospital|