5 research outputs found
Prédiction du besoin transfusionnel chez le patient traumatisé hémodynamiquement stable par la mesure du lactate capillaire au déchocage
Après un accident traumatique environ 25% des patients traumatisés graves hémodynamiquement stables vont être transfusés, avec une morbi-mortalité plus élevée que celle des patients non transfusés. Le lactate sanguin est un marqueur reconnu de transfusion sanguine chez les patients traumatisés. L'objectif de notre étude était d'évaluer si un lactate capillaire supérieur à 3,5mmol/L était prédictif d'une transfusion de plus de 4CGR chez les patients traumatisés graves hémodynamiquement stables. Il s'agit d'une étude prospective observationnelle avec 120 patients inclus. Une différence significative a été retrouvée entre le groupe hyperlactatémie capillaire et le groupe normolactatémie capillaire concernant la transfusion sanguine. La valeur prédictive négative pour la transfusion de 4 CGR était de 100% pour le seuil de 3,5mmol/l. Le lactate capillaire peut donc être un outil intéressant dans l'évaluation des patients traumatisés graves hémodynamiquement stables.GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF
Dynamics of clinical recovery during the early phase of rehabilitation in patients with severe traumatic and non-traumatic brain injury
Additional file 1: of Capillary lactate concentration on admission of normotensive trauma patients: a prospective study
Detailed data of the receiver operating characteristic curves for capillary lactate and shock index to predict significant tranfusion. (DOCX 25 kb
Capillary lactate concentration on admission of normotensive trauma patients: a prospective study
Penumbral Rescue by Normobaric O=O Administration in Patients with Ischemic Stroke and Target Mismatch ProFile (PROOF): Study Protocol of a Phase IIb Trial.
RATIONALE
Oxygen is essential for cellular energy metabolism. Neurons are particularly vulnerable to hypoxia. Increasing oxygen supply shortly after stroke onset could preserve the ischemic penumbra until revascularization occurs.
AIMS
PROOF investigates the use of normobaric oxygen therapy (NBO) within six hours of symptom onset/notice for brain-protective bridging until endovascular revascularization of acute intracranial anterior circulation occlusion.
METHODS AND DESIGN
Randomized (1:1), standard treatment-controlled, open-label, blinded endpoint, multicenter adaptive phase IIb trial.
STUDY OUTCOMES
Primary outcome is ischemic core growth (mL) from baseline to 24 hours (intention-to-treat analysis). Secondary efficacy outcomes include change in NIHSS from baseline to 24 hours, mRS at 90 days, cognitive and emotional function, and quality of life. Safety outcomes include mortality, intracranial hemorrhage, and respiratory failure. Exploratory analyses of imaging and blood biomarkers are conducted.
SAMPLE SIZE
Using an adaptive design with interim analysis at 80 patients per arm, up to 456 participants (228 per arm) would be needed for 80% power (one-sided alpha 0.05) to detect a mean reduction of ischemic core growth by 6.68 mL, assuming 21.4 mL standard deviation.
DISCUSSION
By enrolling endovascular thrombectomy candidates in an early time window, the trial replicates insights from preclinical studies in which NBO showed beneficial effects, namely early initiation of near 100% inspired oxygen during short temporary ischemia. Primary outcome assessment at 24 hours on follow-up imaging reduces potential bias due to withdrawal of care and early clinical confounders such as delayed extubation and aspiration pneumonia.
TRIAL REGISTRATIONS
ClinicalTrials.gov: NCT03500939; EudraCT: 2017-001355-31