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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

  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

Sponsor: Seoul National University Hospital

Current Primary Outcome: Change of volume of perihematomal edema as assessed by brain CT [ Time Frame: 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".


Original Primary Outcome: Brain edema, Significant adverse events, mRS, Bathel index [ Time Frame: one year ]

Current Secondary Outcome:

  • The neurological status at 90 day using E-GOS and mRS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Secondary Outcome: -Clinical assessment; NIHSS /Glasgow Coma Scale -Self-assessment; Barthel index/m-Rankin Scale/Extended Glasgow outcome scale -Brain CT (edema size, hematoma size)

Information By: Seoul National University Hospital

Dates:
Date Received: September 6, 2007
Date Started: October 2007
Date Completion:
Last Updated: April 14, 2016
Last Verified: March 2010