Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage
29. juni 2011 oppdatert av: London School of Hygiene and Tropical Medicine
A Large Randomised Placebo Controlled Trial Among Trauma Patients With, or at Risk of, Significant Haemorrhage, of the Effects of Antifibrinolytic Treatment on Death and Transfusion Requirement
CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requirements.
Adults with trauma who are within 8 hours of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent.
Numbered drug or placebo packs will be available in each participating emergency department.
Randomisation will involve calling a 24-hour freecall randomisation service.
The call should last only a minute or two and at the end of it the randomisation service will specify which numbered treatment pack to use.
For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered treatment pack.
No extra tests are required but a short form must be completed one month later or on discharge or on death (whichever occurs first).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
See trial website for full protocol.
This is an international trial with over 300 hospitals in about 40 countries worldwide.
Studietype
Intervensjonell
Registrering (Faktiske)
20211
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia
- Over 50 countries Worldwide
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
All trauma patients with ongoing significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or who are considered to be at risk of significant haemorrhage, and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better.
Exclusion Criteria:
The fundamental eligibility criterion is the responsible doctor's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 2
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Visual matched placebo
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Eksperimentell: 1
Active
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Loading dose of 1 gram then 1 gram by infusion over 8 hours
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion).
Tidsramme: Death, discharge or four weeks post randomisation whichever occurs first.
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Death, discharge or four weeks post randomisation whichever occurs first.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention, and the occurrence of thrombo-embolic episodes
Tidsramme: Death, discharge or four weeks post randomisation whichever occurs first.
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Death, discharge or four weeks post randomisation whichever occurs first.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Ian Roberts, MD, London School of Hygiene and Tropical Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kolin DA, Shakur-Still H, Bello A, Chaudhri R, Bates I, Roberts I. Risk factors for blood transfusion in traumatic and postpartum hemorrhage patients: Analysis of the CRASH-2 and WOMAN trials. PLoS One. 2020 Jun 3;15(6):e0233274. doi: 10.1371/journal.pone.0233274. eCollection 2020.
- Coats T, Hunt B, Roberts I, Shakur H. Antifibrinolytic agents in traumatic haemorrhage. PLoS Med. 2005 Mar;2(3):e64. doi: 10.1371/journal.pmed.0020064. Epub 2005 Mar 29.
- Edgar K, Roberts I, Sharples L. Including random centre effects in design, analysis and presentation of multi-centre trials. Trials. 2021 May 22;22(1):357. doi: 10.1186/s13063-021-05266-w.
- Nishijima DK, Kuppermann N, Roberts I, VanBuren JM, Tancredi DJ. The Effect of Tranexamic Acid on Functional Outcomes: An Exploratory Analysis of the CRASH-2 Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):79-87. doi: 10.1016/j.annemergmed.2018.11.018. Epub 2019 Jan 12.
- Roberts I, Edwards P, Prieto D, Joshi M, Mahmood A, Ker K, Shakur H. Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms. Trials. 2017 Jan 31;18(1):48. doi: 10.1186/s13063-016-1750-1.
- Roberts I, Prieto-Merino D, Manno D. Mechanism of action of tranexamic acid in bleeding trauma patients: an exploratory analysis of data from the CRASH-2 trial. Crit Care. 2014 Dec 13;18(6):685. doi: 10.1186/s13054-014-0685-8.
- Meurer WJ. Tranexamic acid reduced mortality in trauma patients who were bleeding or at risk for bleeding. Ann Intern Med. 2013 Sep 17;159(6):JC3. doi: 10.7326/0003-4819-159-6-201309170-02003. No abstract available.
- Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
- Williams-Johnson JA, McDonald AH, Strachan GG, Williams EW. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) A randomised, placebo-controlled trial. West Indian Med J. 2010 Dec;59(6):612-24.
- Guerriero C, Cairns J, Perel P, Shakur H, Roberts I; CRASH 2 trial collaborators. Cost-effectiveness analysis of administering tranexamic acid to bleeding trauma patients using evidence from the CRASH-2 trial. PLoS One. 2011 May 3;6(5):e18987. doi: 10.1371/journal.pone.0018987.
- CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
- CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2005
Primær fullføring (Faktiske)
1. februar 2010
Studiet fullført (Faktiske)
1. mars 2010
Datoer for studieregistrering
Først innsendt
11. september 2006
Først innsendt som oppfylte QC-kriteriene
11. september 2006
Først lagt ut (Anslag)
12. september 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. juni 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2011
Sist bekreftet
1. juni 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ISRCTN86750102
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