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

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 - 2018/6/13

Y1 - 2018/6/13

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

SN - 1756-0500

VL - 11

SP - 1

EP - 8

JO - BMC Research Notes

JF - BMC Research Notes

IS - 1

M1 - 379

ER -