CRASH-2

Prediciendo la muerte temprana en pacientes con sangrado por trauma: desarrollo y validación de un modelo pronóstico
Predicting early death in patients with traumatic bleeding: development and validation of prognostic model.
Perel P, Prieto-Merino D, Shakur H, Clayton T, Lecky F, Bouamra O, Russell R, Faulkner M, Steyerberg EW, Roberts I.
Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. pablo.perel@lshtm.ac.uk
BMJ. 2012 Aug 15;345:e5166. doi: 10.1136/bmj.e5166.
Abstract
OBJECTIVE: To develop and validate a prognostic model for early death in patients with traumatic bleeding. DESIGN: Multivariable logistic regression of a large international cohort of trauma patients. SETTING: 274 hospitals in 40 high, medium, and low income countries. PARTICIPANTS:
Prognostic model development: 20,127 trauma patients with, or at risk of, significant bleeding, within 8 hours of injury in the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial. External validation: 14,220 selected trauma patients from the Trauma Audit and Research Network (TARN), which included mainly patients from the UK. OUTCOMES: In-hospital death within 4 weeks of injury. RESULTS: 3076 (15%) patients died in the CRASH-2 trial and 1765 (12%) in the TARN dataset. Glasgow coma score, age, and systolic blood pressure were the strongest predictors of mortality. Other predictors included in the final model were geographical region (low, middle, or high income country), heart rate, time since injury, and type of injury. Discrimination and calibration were satisfactory, with C statistics above 0.80 in both CRASH-2 and TARN. A simple chart was constructed to readily provide the probability of death at the point of care, and a web based calculator is available for a more detailed risk assessment (http://crash2.lshtm.ac.uk). CONCLUSIONS: This prognostic model can be used to obtain valid predictions of mortality in patients with traumatic bleeding, assisting in triage and potentially shortening the time to diagnostic and lifesaving procedures (such as imaging, surgery, and tranexamic acid). Age is an important prognostic factor, and this is of particular relevance in high income countries with an aging trauma population.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419468/pdf/bmj.e5166.pdf




CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage). Estudio de sangrado intracranial: efecto del ácido tranexámico en el daño cerebral traumático.


CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage) intracranial bleeding study: the effect of tranexamic acid in traumatic brain injury--a nested randomised, placebo-controlled trial.
Perel P, Al-Shahi Salman R, Kawahara T, Morris Z, Prieto-Merino D, Roberts I, Sandercock P, Shakur H, Wardlaw J.
London School of Hygiene and Tropical Medicine, London, UK.pablo.perel@lshtm.ac.uk
Health Technol Assess. 2012;16(13):iii-xii, 1-54. doi: 10.3310/hta16130.
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 ≤ 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.


http://www.hta.ac.uk/execsumm/summ1613.htm



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Anestesiología y Medicina del Dolor
www.anestesia-dolor.org