Intracerebral HemorrhageACE-ICHNCT00526214
Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study
A study testing celecoxib medication in people with Intracerebral Hemorrhage, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- celecoxib medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
- Supratentorial location of hemorrhage
- Older than 17 yrs
Who cannot join
- Planned surgical evacuation of hematoma within 24hrs
- Secondary ICH due to trauma or aneurismal rupture or etc
- Taking antithrombotics or other NSAIDs previously
- Pregnancy
- Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this 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
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
Read the detailed description
- INCLUSION/EXCLUSION CRITERIA
- 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
- 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).
- OTHER THERAPY -No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms
- 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
- Conditions
- Intracerebral Hemorrhage
- Being tested
- celecoxib medication
- Keywords
- Spontaneous intracerebral hemorrhage, Acute Spontaneous, Supratentorial intracerebral hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib medicationDrug
Also called celecoxib(celebrex)
In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | In the control group, patients will not take the drug. We do not use placebo drugs. |
| 2 | Experimental | In the intervention group, patients will take celecoxib. Receives: Drug: celecoxib medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: at 1st day of admission and repeated at 7th±1 day
Secondary outcomes (3)
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.
Measured: 90 days after onset.
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
Measured: Day1, Day 7
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
Measured: anytime for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae-Kyu Roh, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526214
- Sponsor's protocol ID
- H-0704-028-205
- Other IDs
- 12-2007-0084
- Acronym
- ACE-ICH
- Status last verified
- Mar 2010
- First submitted
- 6 Sep 2007
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15362723
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00526214
- Acronym / sponsor ID
- ACE-ICH / H-0704-028-205
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Spontaneous intracerebral hemorrhage, Acute Spontaneous, Supratentorial intracerebral hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- INCLUSION/EXCLUSION CRITERIA
- 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
- 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).
- OTHER THERAPY -No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –In the control group, patients will not take the drug. We do not use placebo drugs. |
| 2 | Experimental | Drug: celecoxib medicationIn the intervention group, patients will take celecoxib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
- Supratentorial location of hemorrhage
- Older than 17 yrs
Key exclusion criteria (5 listed)
- Planned surgical evacuation of hematoma within 24hrs
- Secondary ICH due to trauma or aneurismal rupture or etc
- Taking antithrombotics or other NSAIDs previously
- Pregnancy
- Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib medicationAlso: celecoxib(celebrex)In the celecoxib group, patients will take celecoxib 400mg twice (per day), orally for 14 days. | Drug | 2 |
Primary outcome
Change of volume of perihematomal edema as assessed by brain CT
Time frame: at 1st day of admission and repeated at 7th±1 day
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".
3 secondary outcomes
The neurological status at 90 day using E-GOS and mRS
Time frame: 90 days after onset.
Change of ICH volume between the initial and the follow-up CT scans
Time frame: Day1, Day 7
Major and minor adverse events
Time frame: anytime for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 15362723Chu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Kyu Roh, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing celecoxib medication in people with Intracerebral Hemorrhage, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of volume of perihematomal edema as assessed by brain CT (time frame: at 1st day of admission and repeated at 7th±1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.