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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526214
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Jae-Kyu Roh, MD, PhD||Seoul National University Hospital|