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Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial
The Lancet 2018 Cilt 391 Sayı 10135
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391
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2107-2115
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Background: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. Methods: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214. Findings: We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76–1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53–0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77–1·10, p=0·37). Fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]). Interpretation: Functional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect. Funding: National Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation.
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Kaynak: LANCET · s. 2107-2115

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Makale Bilgileri

Dergi The Lancet
ISSN 0140-6736
Yıl 2018 / 5. ay
Cilt / Sayı 391 / 10135
Sayfalar 2107 – 2115
Makale Türü Özgün Makale
Hakemlik Hakemli
Endeks SCI
Teşvik Puanı 0,64 · YÖKSİS Akademik Teşvik
Yayın Dili İngilizce
Kapsam Uluslararası
Toplam Yazar 28 kişi
Erişim Türü Elektronik
Alan Sağlık Bilimleri Temel Alanı- Nöroloji

YÖKSİS Yazar Kaydı

Yazar Adı SPRİGG NİKOLA,FLAHERTY KETIA,APPLETON JASON P,SALMAN RUSTHAM AL SHAHI,BERECKZI DANIEL,CHRISTENSEN HANNE,CICCONE ALFONSO,COLLINS RONAN,CZLONKOWSKA ANNA,DINEEN ROBERT A,DULEY LELIA,EGEA GUERRERO JUAN JOSE,ENGLAND TIMOTHY,KRISHNAN KAILASH,LASKA ANN CHARLOTTE,LAW ZHE KANG,ÖZTÜRK ŞEREFNUR,POCOCK STUART J,ROBERTS IAN,ROBINSON THOMPSON G,ROFFE CHRISTINE,SEIFFGE DAVID,SCUTT POLLY,THANABALAN JEGAN,WERRING DAVID,WHYNES DAVID,BATH PHILIP M,EKMEKCİ AHMET HAKAN
YÖKSİS ID 3862719

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Scopus Atıf 426
Havuz Atıfları 0
Teşvik Puanı 0,64
Yazar Sayısı 28