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Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign

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Harvard

Ovesen, C, Jakobsen, JC, Gluud, C, Steiner, T, Law, Z, Flaherty, K, Dineen, RA, Christensen, LM, Overgaard, K, Rasmussen, RS, Bath, PM, Sprigg, N, Christensen, H & TICH-2 Investigators 2021, 'Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign', Stroke, vol. 52, no. 8, pp. 2629-2636. https://doi.org/10.1161/STROKEAHA.120.032426

APA

Ovesen, C., Jakobsen, J. C., Gluud, C., Steiner, T., Law, Z., Flaherty, K., Dineen, R. A., Christensen, L. M., Overgaard, K., Rasmussen, R. S., Bath, P. M., Sprigg, N., Christensen, H., & TICH-2 Investigators (2021). Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign. Stroke, 52(8), 2629-2636. https://doi.org/10.1161/STROKEAHA.120.032426

CBE

Ovesen C, Jakobsen JC, Gluud C, Steiner T, Law Z, Flaherty K, Dineen RA, Christensen LM, Overgaard K, Rasmussen RS, Bath PM, Sprigg N, Christensen H, TICH-2 Investigators. 2021. Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign. Stroke. 52(8):2629-2636. https://doi.org/10.1161/STROKEAHA.120.032426

MLA

Vancouver

Author

Ovesen, Christian ; Jakobsen, Janus Christian ; Gluud, Christian ; Steiner, Thorsten ; Law, Zhe ; Flaherty, Katie ; Dineen, Rob A ; Christensen, Louisa M ; Overgaard, Karsten ; Rasmussen, Rune S ; Bath, Philip M ; Sprigg, Nikola ; Christensen, Hanne ; TICH-2 Investigators. / Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign. In: Stroke. 2021 ; Vol. 52, No. 8. pp. 2629-2636.

Bibtex

@article{780b15affb924e5ea254d85915b50d9b,
title = "Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign",
abstract = "BACKGROUND AND PURPOSE: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We investigated, if spot-sign positive participants benefit more from tranexamic acid versus placebo as compared to spot-sign negative participants.METHODS: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status.RESULTS: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI, -12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI, -8.4% to 12.8%) for spot-sign negative participants (Pheterogenity=0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants (Pheterogenity=0.88).CONCLUSIONS: Data from the TICH-2 trial do not support that admission spot sign status modifies the treatment effect of tranexamic acid versus placebo in patients with acute intracerebral hemorrhage. The results might have been affected by low statistical power as well as treatment delay.REGISTRATION: URL: http://www.controlled-trials.com; Unique identifier: ISRCTN93732214.",
keywords = "angiography, cerebral hemorrhage, computed tomography angiography, hematoma, tranexamic acid, Humans, Middle Aged, Tranexamic Acid/therapeutic use, Cerebral Hemorrhage/diagnostic imaging, Male, Tomography, X-Ray Computed, Treatment Outcome, Computed Tomography Angiography, Disease Progression, Cerebral Angiography, Antifibrinolytic Agents/therapeutic use, Aged, 80 and over, Female, Aged, Hematoma/diagnostic imaging",
author = "Christian Ovesen and Jakobsen, {Janus Christian} and Christian Gluud and Thorsten Steiner and Zhe Law and Katie Flaherty and Dineen, {Rob A} and Christensen, {Louisa M} and Karsten Overgaard and Rasmussen, {Rune S} and Bath, {Philip M} and Nikola Sprigg and Hanne Christensen and {TICH-2 Investigators}",
year = "2021",
month = aug,
doi = "10.1161/STROKEAHA.120.032426",
language = "English",
volume = "52",
pages = "2629--2636",
journal = "Journal of Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams & Wilkins",
number = "8",

}

RIS

TY - JOUR

T1 - Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign

AU - Ovesen, Christian

AU - Jakobsen, Janus Christian

AU - Gluud, Christian

AU - Steiner, Thorsten

AU - Law, Zhe

AU - Flaherty, Katie

AU - Dineen, Rob A

AU - Christensen, Louisa M

AU - Overgaard, Karsten

AU - Rasmussen, Rune S

AU - Bath, Philip M

AU - Sprigg, Nikola

AU - Christensen, Hanne

AU - TICH-2 Investigators

PY - 2021/8

Y1 - 2021/8

N2 - BACKGROUND AND PURPOSE: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We investigated, if spot-sign positive participants benefit more from tranexamic acid versus placebo as compared to spot-sign negative participants.METHODS: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status.RESULTS: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI, -12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI, -8.4% to 12.8%) for spot-sign negative participants (Pheterogenity=0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants (Pheterogenity=0.88).CONCLUSIONS: Data from the TICH-2 trial do not support that admission spot sign status modifies the treatment effect of tranexamic acid versus placebo in patients with acute intracerebral hemorrhage. The results might have been affected by low statistical power as well as treatment delay.REGISTRATION: URL: http://www.controlled-trials.com; Unique identifier: ISRCTN93732214.

AB - BACKGROUND AND PURPOSE: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We investigated, if spot-sign positive participants benefit more from tranexamic acid versus placebo as compared to spot-sign negative participants.METHODS: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status.RESULTS: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI, -12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI, -8.4% to 12.8%) for spot-sign negative participants (Pheterogenity=0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants (Pheterogenity=0.88).CONCLUSIONS: Data from the TICH-2 trial do not support that admission spot sign status modifies the treatment effect of tranexamic acid versus placebo in patients with acute intracerebral hemorrhage. The results might have been affected by low statistical power as well as treatment delay.REGISTRATION: URL: http://www.controlled-trials.com; Unique identifier: ISRCTN93732214.

KW - angiography

KW - cerebral hemorrhage

KW - computed tomography angiography

KW - hematoma

KW - tranexamic acid

KW - Humans

KW - Middle Aged

KW - Tranexamic Acid/therapeutic use

KW - Cerebral Hemorrhage/diagnostic imaging

KW - Male

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

KW - Computed Tomography Angiography

KW - Disease Progression

KW - Cerebral Angiography

KW - Antifibrinolytic Agents/therapeutic use

KW - Aged, 80 and over

KW - Female

KW - Aged

KW - Hematoma/diagnostic imaging

UR - http://www.scopus.com/inward/record.url?scp=85111441405&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.120.032426

DO - 10.1161/STROKEAHA.120.032426

M3 - Journal article

C2 - 34000834

VL - 52

SP - 2629

EP - 2636

JO - Journal of Stroke

JF - Journal of Stroke

SN - 0039-2499

IS - 8

ER -

ID: 66257122