Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study — ACE-ICH  

Intracerebral Hemorrhage Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

• NCT number: NCT00526214
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Completion date: August 2009