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

Intracerebral Hemorrhage Clinical Trial

— ACE-ICH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526214
• Other study ID #: H-0704-028-205
• Secondary ID: 12-2007-0084
• Status: Completed
• Phase: N/A
• First received: September 6, 2007
• Last updated: April 14, 2016
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: March 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

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

Intervention

Drug:
• celecoxib medication
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of volume of perihematomal edema as assessed by brain CT	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".	at 1st day of admission and repeated at 7th±1 day	No
Secondary	The neurological status at 90 day using E-GOS and mRS	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.	90 days after onset.	No
Secondary	Change of ICH volume between the initial and the follow-up CT scans	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	Day1, Day 7	No
Secondary	Major and minor adverse events	the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study	anytime for 3 months	Yes