Abstract Number: PB0410
Meeting: ISTH 2021 Congress
Background: Intracerebral haemorrhage (ICH) can be devastating with high early mortality and disability in survivors, with outcome related to volume of haematoma and haematoma growth. Tranexamic acid (TXA) reduces mortality in other bleeding conditions when given early and reduced haematoma growth in previous study, TICH-2.
Aims: To assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice.
Methods: Pragmatic phase III prospective blinded randomised placebo-controlled trial.
Setting: Emergency departments, acute stroke units across the UK and worldwide. Estimated 100 UK sites, 65 non-UK sites.
Participants: Adult patients with ICH confirmed on brain imaging within 4.5 hours of symptom onset. Exclusion: Contraindication for TXA, patient known to be taking anti-coagulation, Glasgow coma scale (GCS) <5, estimated haematoma volume (HV) > 60mls, palliative care.
Intervention: intravenous TXA 2g given as 1g bolus in 100 ml normal saline 0.9% infusion over 10 min and 1g infusion in 250 ml normal saline 0.9% over 8 hours or placebo (normal saline 0.9%) administered by an identical regimen. Randomisation will be to TXA vs. placebo in a 1:1 ratio.
Primary outcome: mortality at 7 days,
Secondary outcome: modified Rankin Scale at (mRS) 180 days.
Timelines for delivery: 7.25 years project; 3 month develop protocol ready for submissions, 9 month set up to obtain regulatory approvals, team recruitment and produce the trial treatment, 5.25 years participant recruitment in the UK, 4.75 years in International sites, 6 months final follow-up, 6 months data clean, analysis and dissemination.
Conclusions: TXA is affordable, widely available, already utilised in other fields (trauma, gynaecology, cardiology) worldwide. If the trial confirms that TXA is effective, TXA could be rapidly implemented into the clinical pathway for ICH and has the potential for global impact reducing mortality.
To cite this abstract in AMA style:Desborough M, Al-Shahi Salman R, Coats T, Dineen R, England T, Havard D, Hepburn T, Hodgson S, James M, Montgomery A, Rick C, Roberts I, Robinson T, Roffe C, Werring D, Bath P, Sprigg N. Tranexamic acid for Hyperacute Primary Intracerebral Haemorrhage (TICH-3): Protocol for a Multinational Phase 3 Placebo-controlled Randomised Trial [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-3-protocol-for-a-multinational-phase-3-placebo-controlled-randomised-trial/. Accessed November 29, 2021.
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