Journals Library

An error occurred retrieving content to display, please try again.

Page not found (404)

Sorry - the page you requested could not be found.

Please choose a page from the navigation or try a website search above to find the information you need.

Study to evaluate the effect of tranexamic acid in traumatic brain injury patients found that neither moderate benefits nor moderate harmful effects can be excluded and that, although uncertainty remains, tranexamic administration might improve outcome in traumatic brain injury patients.

{{author}}{{author}}{{($index < metadata.AuthorsAndEtalArray.length-1) ? ',' : '.'}}

P Perel, R Al-Shahi Salman, T Kawahara, Z Morris, D Prieto-Merino, I Roberts, P Sandercock, H Shakur & J Wardlaw.

P Perel 1,*, R Al-Shahi Salman 2, T Kawahara 1, Z Morris 2, D Prieto-Merino 1, I Roberts 1, P Sandercock 2, H Shakur 1, J Wardlaw 2

1 London School of Hygiene and Tropical Medicine, Keppel Street, London, UK
2 Division of Clinical Neurosciences, Western General Hospital, Edinburgh, UK
* Corresponding author Email: pablo.perel@lshtm.ac.uk

Funding: {{metadata.Funding}}

{{metadata.Journal}} Volume: {{metadata.Volume}}, Issue: {{metadata.Issue}}, Published in {{metadata.PublicationDate | date:'MMMM yyyy'}}

https://doi.org/{{metadata.DOI}}

Citation: {{author}}{{ (($index < metadata.AuthorsArray.length-1) && ($index <=6)) ? ', ' : '' }}{{(metadata.AuthorsArray.length <= 6) ? '.' : '' }} {{(metadata.AuthorsArray.length > 6) ? 'et al.' : ''}} . {{metadata.JournalShortName}} {{metadata.PublicationDate | date:'yyyy'}};{{metadata.Volume}}({{metadata.Issue}})

Crossmark status check

Report Content

The full text of this issue is available as a PDF document from the Toolkit section on this page.

The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Tranexamic acid (TXA) has been shown to reduce blood loss in surgical patients and the risk of death in patients with traumatic bleeding, with no apparent increase in vascular occlusive events. These findings raise the possibility that it might also be effective in traumatic brain injury (TBI).

OBJECTIVE

The Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage Intracranial Bleeding Study (CRASH-2 IBS) was conducted to quantify the effect of an early short course of TXA on intracranial haemorrhage and new focal cerebral ischaemic lesions in patients with TBI.

DESIGN

CRASH-2 IBS was a prospective randomised controlled trial nested within the CRASH-2 trial. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight. We used a local pack system that selected the lowest numbered treatment pack from a box containing eight numbered packs. Apart from the pack number, the treatment packs were identical. The pack number was recorded on the entry form, which was sent to the international trial co-ordinating centre in London, UK. Once the treatment pack number was recorded, the patient was included in the trial whether or not the treatment pack was opened or the allocated treatment started. All site investigators and trial co-ordinating centre staff were masked to treatment allocation.

SETTING

Ten hospitals: (India) Aditya Neuroscience Centre, Sanjivani Hospital, CARE Hospital, Christian Medical College, Medical Trust Hospital, Jeevan Jyoti Hospital and (Colombia) Hospital Universitario San Vicente de Paul, Hospital Pablo Tobón Uribe, Hospital Universitario San José de Popayán and Fundación Valle del Lili.

PARTICIPANTS

The trial was conducted in a subset of 270 CRASH-2 trial participants. Patients eligible for inclusion in the CRASH-2 IBS fulfilled the inclusion criteria for the CRASH-2 trial, and also had TBI [Glasgow Coma Scale score of â ¤ 14 and a brain computerised tomography (CT) scan compatible with TBI]. Pregnant women and patients for whom a second brain CT scan was not possible were excluded.

INTERVENTIONS

Participants were randomly allocated to receive either a loading dose of 1 g of TXA infused over 10 minutes followed by an intravenous infusion of 1 g over 8 hours or matching placebo.

MAIN OUTCOME MEASURE

The primary outcome was the increase in size of intracranial haemorrhage growth between a CT scan at hospital admission and a second scan 24-48 hours later.

RESULTS

One hundred and thirty-three patients were allocated to TXA and 137 to placebo, of whom information on the primary (imaging) outcome was available for 123 (92%) and 126 (92%) respectively. The analysis suggested that TXA was likely to be associated with a reduction in haemorrhage growth [adjusted difference -3.8 ml, 95% credibility interval (CrI) -11.5 ml to 3.9 ml], fewer focal ischaemic lesions [adjusted odds ratio (OR) 0.54, 95% CrI 0.20 to 1.46] and fewer deaths (adjusted OR 0.49, 95% CrI 0.22 to 1.06).

CONCLUSIONS

This was the first randomised controlled study to evaluate the effect of TXA in TBI patients and it found that neither moderate benefits nor moderate harmful effects can be excluded. However, although uncertainty remains, our analyses suggest that TXA administration might improve outcome in TBI patients and provide grounds for evaluating this hypothesis in future research.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86750102.

SOURCE OF FUNDING

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 13. See the HTA programme website for further project information.

Abstract

BACKGROUND

Tranexamic acid (TXA) has been shown to reduce blood loss in surgical patients and the risk of death in patients with traumatic bleeding, with no apparent increase in vascular occlusive events. These findings raise the possibility that it might also be effective in traumatic brain injury (TBI).

OBJECTIVE

The Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage Intracranial Bleeding Study (CRASH-2 IBS) was conducted to quantify the effect of an early short course of TXA on intracranial haemorrhage and new focal cerebral ischaemic lesions in patients with TBI.

DESIGN

CRASH-2 IBS was a prospective randomised controlled trial nested within the CRASH-2 trial. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight. We used a local pack system that selected the lowest numbered treatment pack from a box containing eight numbered packs. Apart from the pack number, the treatment packs were identical. The pack number was recorded on the entry form, which was sent to the international trial co-ordinating centre in London, UK. Once the treatment pack number was recorded, the patient was included in the trial whether or not the treatment pack was opened or the allocated treatment started. All site investigators and trial co-ordinating centre staff were masked to treatment allocation.

SETTING

Ten hospitals: (India) Aditya Neuroscience Centre, Sanjivani Hospital, CARE Hospital, Christian Medical College, Medical Trust Hospital, Jeevan Jyoti Hospital and (Colombia) Hospital Universitario San Vicente de Paul, Hospital Pablo Tobón Uribe, Hospital Universitario San José de Popayán and Fundación Valle del Lili.

PARTICIPANTS

The trial was conducted in a subset of 270 CRASH-2 trial participants. Patients eligible for inclusion in the CRASH-2 IBS fulfilled the inclusion criteria for the CRASH-2 trial, and also had TBI [Glasgow Coma Scale score of â ¤ 14 and a brain computerised tomography (CT) scan compatible with TBI]. Pregnant women and patients for whom a second brain CT scan was not possible were excluded.

INTERVENTIONS

Participants were randomly allocated to receive either a loading dose of 1 g of TXA infused over 10 minutes followed by an intravenous infusion of 1 g over 8 hours or matching placebo.

MAIN OUTCOME MEASURE

The primary outcome was the increase in size of intracranial haemorrhage growth between a CT scan at hospital admission and a second scan 24-48 hours later.

RESULTS

One hundred and thirty-three patients were allocated to TXA and 137 to placebo, of whom information on the primary (imaging) outcome was available for 123 (92%) and 126 (92%) respectively. The analysis suggested that TXA was likely to be associated with a reduction in haemorrhage growth [adjusted difference -3.8 ml, 95% credibility interval (CrI) -11.5 ml to 3.9 ml], fewer focal ischaemic lesions [adjusted odds ratio (OR) 0.54, 95% CrI 0.20 to 1.46] and fewer deaths (adjusted OR 0.49, 95% CrI 0.22 to 1.06).

CONCLUSIONS

This was the first randomised controlled study to evaluate the effect of TXA in TBI patients and it found that neither moderate benefits nor moderate harmful effects can be excluded. However, although uncertainty remains, our analyses suggest that TXA administration might improve outcome in TBI patients and provide grounds for evaluating this hypothesis in future research.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86750102.

SOURCE OF FUNDING

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 13. See the HTA programme website for further project information.

If you would like to receive a notification when this project publishes in the NIHR Journals Library, please submit your email address below.

 

Responses to this report

No responses have been published.

 

If you would like to submit a response to this publication, please do so using the form below:

Comments submitted to the NIHR Journals Library are electronic letters to the editor. They enable our readers to debate issues raised in research reports published in the Journals Library. We aim to post within 14 working days all responses that contribute substantially to the topic investigated, as determined by the Editors.  Non-relevant comments will be deleted.

Your name and affiliations will be published with your comment.

Once published, you will not have the right to remove or edit your response. The Editors may add, remove, or edit comments at their absolute discretion.

By submitting your response, you are stating that you agree to the terms & conditions