NCT00526214

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 15, 2016

Status Verified

March 1, 2010

Enrollment Period

1.6 years

First QC Date

September 6, 2007

Last Update Submit

April 14, 2016

Conditions

Intracerebral Hemorrhage

Keywords

Spontaneous intracerebral hemorrhageAcute Spontaneous, Supratentorial intracerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • The neurological status at 90 day using E-GOS and mRS

    90 days after onset.

  • Change of ICH volume between the initial and the follow-up CT scans

    Day1, Day 7

  • Major and minor adverse events

    anytime for 3 months

Study Arms (2)

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.

Drug: celecoxib medication

Interventions

celecoxib medicationDRUG

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

Also known as: celecoxib(celebrex)
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
  • Supratentorial location of hemorrhage
  • Older than 17 yrs

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related 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. doi: 10.1097/01.WCB.0000130866.25040.7D.

    PMID: 15362723BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jae-Kyu Roh, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

April 15, 2016

Record last verified: 2010-03

Locations

KR(1)