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

Seoul National University

Status: Completed

Conditions: Intracerebral Hemorrhage

Treatments: Drug: celecoxib medication

Study type: Interventional

Funder types: Other

Identifiers

NCT00526214

H-0704-028-205

12-2007-0084

Details and patient eligibility

About

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

Full 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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

1

No Intervention group

Description:

In the control group, patients will not take the drug. We do not use placebo drugs.

2

Experimental group

Description:

In the intervention group, patients will take celecoxib.

Treatment:

Drug: celecoxib medication