Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial
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Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan : a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial. / Ovesen, Christian; Jakobsen, Janus Christian; Gluud, Christian; Steiner, Thorsten; Law, Zhe; Flaherty, Katie; Dineen, Rob A; Bath, Philip M; Sprigg, Nikola; Christensen, Hanne.
In: BMC Research Notes, Vol. 11, No. 1, 379, 2018, p. 1-8.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan
T2 - a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial
AU - Ovesen, Christian
AU - Jakobsen, Janus Christian
AU - Gluud, Christian
AU - Steiner, Thorsten
AU - Law, Zhe
AU - Flaherty, Katie
AU - Dineen, Rob A
AU - Bath, Philip M
AU - Sprigg, Nikola
AU - Christensen, Hanne
PY - 2018
Y1 - 2018
N2 - OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).
AB - OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).
KW - Antifibrinolytic Agents/administration & dosage
KW - Cerebral Hemorrhage/diagnostic imaging
KW - Data Interpretation, Statistical
KW - Disease Progression
KW - Hematoma/diagnostic imaging
KW - Humans
KW - Outcome Assessment (Health Care)/statistics & numerical data
KW - Tranexamic Acid/administration & dosage
U2 - 10.1186/s13104-018-3481-8
DO - 10.1186/s13104-018-3481-8
M3 - Journal article
C2 - 29895329
VL - 11
SP - 1
EP - 8
JO - BMC Research Notes
JF - BMC Research Notes
SN - 1756-0500
IS - 1
M1 - 379
ER -
ID: 222256280