Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage: A multicenter randomized controlled trial

Seung Hoon Lee, H. K. Park, W. S. Ryu, J. S. Lee, Hee-Joon Bae, Moon-Ku Han, Yong Seok Lee, Hyung-Min Kwon, C. K. Kim, E. S. Park, J. W. Chung, Kunhwa Jung, J. K. Roh

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Abstract

Background and purpose: We investigated the effect of celecoxib, a selective inhibitor of cyclo-oxygenase 2, in patients with intracerebral hemorrhage (ICH). Methods: We conducted a multicenter, randomized, controlled, and open with blinded end-point trial of 44 Korean patients 18years or older with ICH within 24h of onset. The intervention group (n=20) received celecoxib (400mg twice a day) for 14days. The control group (n=24) received the standard medical treatment for ICH. The primary end-point was the number of patients with a change in the volume of perihematomal edema (PHE) from the 1st to the 7th±1day (cut-off value, 20%). Results: The time from onset to computed tomography scan slightly differed between groups (177±160min for control vs. 297±305min for the celecoxib group; P=0.10). In the primary end-point analysis using cut-off values, there was a significant shift to reduced expansion of PHE in the celecoxib group (P=0.005). With respect to the secondary end-points, there was also a significant shift to reduced expansion of ICH in the celecoxib group (P=0.046). In addition, the expansion rate of PHE at follow-up tended to be higher in the control group than in the celecoxib group (90.6±91.7% vs. 44.4±64.9%; P=0.058). Conclusions: In our small, pilot trial, administration of celecoxib in the acute stage of ICH was associated with a smaller expansion of PHE than that observed in controls.

Original languageEnglish
Pages (from-to)1161-1169
Number of pages9
JournalEuropean Journal of Neurology
Volume20
Issue number8
DOIs
StatePublished - 1 Aug 2013

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Celecoxib
Cerebral Hemorrhage
Hematoma
Edema
Randomized Controlled Trials
Control Groups
Cyclooxygenase Inhibitors

Keywords

  • Brain edema
  • Celecoxib
  • Clinical trial
  • Intracerebral hemorrhage

Cite this

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title = "Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage: A multicenter randomized controlled trial",
abstract = "Background and purpose: We investigated the effect of celecoxib, a selective inhibitor of cyclo-oxygenase 2, in patients with intracerebral hemorrhage (ICH). Methods: We conducted a multicenter, randomized, controlled, and open with blinded end-point trial of 44 Korean patients 18years or older with ICH within 24h of onset. The intervention group (n=20) received celecoxib (400mg twice a day) for 14days. The control group (n=24) received the standard medical treatment for ICH. The primary end-point was the number of patients with a change in the volume of perihematomal edema (PHE) from the 1st to the 7th±1day (cut-off value, 20{\%}). Results: The time from onset to computed tomography scan slightly differed between groups (177±160min for control vs. 297±305min for the celecoxib group; P=0.10). In the primary end-point analysis using cut-off values, there was a significant shift to reduced expansion of PHE in the celecoxib group (P=0.005). With respect to the secondary end-points, there was also a significant shift to reduced expansion of ICH in the celecoxib group (P=0.046). In addition, the expansion rate of PHE at follow-up tended to be higher in the control group than in the celecoxib group (90.6±91.7{\%} vs. 44.4±64.9{\%}; P=0.058). Conclusions: In our small, pilot trial, administration of celecoxib in the acute stage of ICH was associated with a smaller expansion of PHE than that observed in controls.",
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Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage : A multicenter randomized controlled trial. / Lee, Seung Hoon; Park, H. K.; Ryu, W. S.; Lee, J. S.; Bae, Hee-Joon; Han, Moon-Ku; Lee, Yong Seok; Kwon, Hyung-Min; Kim, C. K.; Park, E. S.; Chung, J. W.; Jung, Kunhwa; Roh, J. K.

In: European Journal of Neurology, Vol. 20, No. 8, 01.08.2013, p. 1161-1169.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage

T2 - A multicenter randomized controlled trial

AU - Lee, Seung Hoon

AU - Park, H. K.

AU - Ryu, W. S.

AU - Lee, J. S.

AU - Bae, Hee-Joon

AU - Han, Moon-Ku

AU - Lee, Yong Seok

AU - Kwon, Hyung-Min

AU - Kim, C. K.

AU - Park, E. S.

AU - Chung, J. W.

AU - Jung, Kunhwa

AU - Roh, J. K.

PY - 2013/8/1

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N2 - Background and purpose: We investigated the effect of celecoxib, a selective inhibitor of cyclo-oxygenase 2, in patients with intracerebral hemorrhage (ICH). Methods: We conducted a multicenter, randomized, controlled, and open with blinded end-point trial of 44 Korean patients 18years or older with ICH within 24h of onset. The intervention group (n=20) received celecoxib (400mg twice a day) for 14days. The control group (n=24) received the standard medical treatment for ICH. The primary end-point was the number of patients with a change in the volume of perihematomal edema (PHE) from the 1st to the 7th±1day (cut-off value, 20%). Results: The time from onset to computed tomography scan slightly differed between groups (177±160min for control vs. 297±305min for the celecoxib group; P=0.10). In the primary end-point analysis using cut-off values, there was a significant shift to reduced expansion of PHE in the celecoxib group (P=0.005). With respect to the secondary end-points, there was also a significant shift to reduced expansion of ICH in the celecoxib group (P=0.046). In addition, the expansion rate of PHE at follow-up tended to be higher in the control group than in the celecoxib group (90.6±91.7% vs. 44.4±64.9%; P=0.058). Conclusions: In our small, pilot trial, administration of celecoxib in the acute stage of ICH was associated with a smaller expansion of PHE than that observed in controls.

AB - Background and purpose: We investigated the effect of celecoxib, a selective inhibitor of cyclo-oxygenase 2, in patients with intracerebral hemorrhage (ICH). Methods: We conducted a multicenter, randomized, controlled, and open with blinded end-point trial of 44 Korean patients 18years or older with ICH within 24h of onset. The intervention group (n=20) received celecoxib (400mg twice a day) for 14days. The control group (n=24) received the standard medical treatment for ICH. The primary end-point was the number of patients with a change in the volume of perihematomal edema (PHE) from the 1st to the 7th±1day (cut-off value, 20%). Results: The time from onset to computed tomography scan slightly differed between groups (177±160min for control vs. 297±305min for the celecoxib group; P=0.10). In the primary end-point analysis using cut-off values, there was a significant shift to reduced expansion of PHE in the celecoxib group (P=0.005). With respect to the secondary end-points, there was also a significant shift to reduced expansion of ICH in the celecoxib group (P=0.046). In addition, the expansion rate of PHE at follow-up tended to be higher in the control group than in the celecoxib group (90.6±91.7% vs. 44.4±64.9%; P=0.058). Conclusions: In our small, pilot trial, administration of celecoxib in the acute stage of ICH was associated with a smaller expansion of PHE than that observed in controls.

KW - Brain edema

KW - Celecoxib

KW - Clinical trial

KW - Intracerebral hemorrhage

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