Actively Recruiting
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Led by National Taiwan University Hospital · Updated on 2024-09-20
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a phase IIa human clinical study, in which 60 patients with intracerebral hemorrhage (ICH) at basal ganglion or thalamus within 6 h after onset will be enrolled. Patients will be randomly assigned as treatment group or control group as 1:1 distribution. Early initiation of celecoxib within 6 h after ICH and treatment for 21 days will be performed. The safety will be evaluated by drug adverse effects. The efficacy will be assessed by hematoma expansion, brain edema, and 3-month modified Rankin scale.
CONDITIONS
Official Title
Effects and Mechanisms of Celecoxib on Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute intracerebral hemorrhage patients able to take first dose within 6 hours after onset
- Hemorrhage located at basal ganglion or thalamus
- Hematoma volume less than 30 mL
- Normal kidney function (creatinine 64 1.3 mg/dL)
- No indication for surgery
- Signed informed consent
- Consciousness clear or mild drowsiness
- Age between 20 and 80 years old
You will not qualify if you...
- Allergy to celecoxib or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Coronary artery bypass graft surgery within last 14 days
- Previous myocardial infarction
- Previous peptic ulcer disease
- Abnormal kidney function (creatinine > 1.3 mg/dL)
- Surgery for current intracerebral hemorrhage
- Pregnancy or breastfeeding
- Premorbid modified Rankin scale score greater than or equal to 3
- Previous intracerebral hemorrhage not in basal ganglia or thalamus
- Blood clotting abnormalities or use of anticoagulant or antiplatelet drugs
- Abnormal liver function (ALT > 3 times upper limit)
- History of severe bleeding requiring hospital admission or blood transfusion
- History of stenting or valve replacement requiring long-term antithrombotic use
AI-Screening
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Trial Site Locations
Total: 1 location
1
Natinal Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
S
Shin-Joe Yeh, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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