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OpenTrials
Completed

NCT Number: NCT00526214

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

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

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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).

Treatment and study plan

celecoxib medication

Drug

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

Other names: celecoxib(celebrex)

Primary outcomes

  1. 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".

Secondary outcomes

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

    Time frame: 90 days after onset.

    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.

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

    Time frame: Day1, Day 7

    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

  3. Major and minor adverse events

    Time frame: anytime for 3 months

    the cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: ACE-ICH

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2007
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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