Clinical trial NCT00526214: Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: Spontaneous intracerebral hemorrhage
Acute Spontaneous, Supratentorial intracerebral hemorrhage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: Inclusion Criteria:

1. Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
2. Supratentorial location of hemorrhage
3. Older than 17 yrs

Exclusion Criteria:

1. Planned surgical evacuation of hematoma within 24hrs
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).

Primary outcomes:
measure: Change of volume of perihematomal edema as assessed by brain CT
timeFrame: at 1st day of admission and repeated at 7th±1 day
Secondary outcomes:
measure: The neurological status at 90 day using E-GOS and mRS
timeFrame: 90 days after onset.
measure: Change of ICH volume between the initial and the follow-up CT scans
timeFrame: Day1, Day 7
measure: Major and minor adverse events
timeFrame: anytime for 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Kyu Roh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.