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A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2).

ABSTRACT: Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made total-body CT scanning technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate total-body CT leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate total-body CT scanning in trauma patients.The REACT-2 trial is an international, multicenter randomized clinical trial. All participating trauma centers have a multi-slice CT scanner located in the trauma room or at the Emergency Department (ED). All adult, non-pregnant, severely injured trauma patients according to predefined criteria will be included. Patients in whom direct scanning will hamper necessary cardiopulmonary resuscitation or who require an immediate operation because of imminent death (both as judged by the trauma team leader) are excluded. Randomization will be computer assisted. The intervention group will receive a contrast-enhanced total-body CT scan (head to pelvis) during the primary survey. The control group will be evaluated according to local conventional trauma imaging protocols (based on ATLS guidelines) supplemented with selective CT scanning. Primary outcome will be in-hospital mortality. Secondary outcomes are differences in mortality and morbidity during the first year post trauma, several trauma work-up time intervals, radiation exposure, general health and quality of life at 6 and 12 months post trauma and cost-effectiveness.The REACT-2 trial is a multicenter randomized clinical trial that will provide evidence on the value of immediate total-body CT scanning during the primary survey of severely injured trauma patients. If immediate total-body CT scanning is found to be the best imaging strategy in severely injured trauma patients it could replace conventional imaging supplemented with CT in this specific group.ClinicalTrials.gov: (NCT01523626).

SUBMITTER: Sierink JC

PROVIDER: S-EPMC3361475 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2).

Sierink Joanne C JC Saltzherr Teun Peter TP Beenen Ludo F M LF Luitse Jan S K JS Hollmann Markus W MW Reitsma Johannes B JB Edwards Michael J R MJ Hohmann Joachim J Beuker Benn J A BJ Patka Peter P Suliburk James W JW Dijkgraaf Marcel G W MG Goslings J Carel JC

BMC emergency medicine 20120330

<h4>Background</h4>Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made total-body CT scanning technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate total-body CT leads to better clinical outcome then conventional radiog ...[more]

PMID: 22458247

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Project description:BackgroundThe treatment of posttraumatic stress disorder (PTSD) related to a history of sexual and/or physical abuse in childhood is the subject of international debate, with some favouring a phase-based approach as their preferred treatment, while others argue for immediate trauma-focused treatment. A history of (chronic) traumatisation during childhood has been linked to the development of distinct symptoms that are often labelled as symptoms of complex PTSD. Many therapists associate the presence of symptoms of complex PTSD with a less favourable treatment prognosis. The purpose of this study is to determine whether a phase-based approach is more effective than stand-alone trauma-focused therapy in individuals with PTSD and possible symptoms of complex PTSD resulting from a history of repeated sexual and/or physical abuse in childhood. An additional aim is to investigate moderators, predictors of treatment (non) response and drop-out.MethodThe sample consists of patients between 18 and 65 years old with a diagnosis of PTSD who report a history of repeated sexual and/or physical abuse in childhood (N?=?122). Patients will be blindly allocated to either 16 sessions of eye movement desensitization and reprocessing (EMDR) therapy preceded by a stabilization phase (eight sessions of Skills Training in Affect and Interpersonal Regulation (STAIR)) or only 16 sessions of EMDR therapy. Assessments are carried out pre-treatment, after every eighth session, post-treatment, and at 3 and 6 months follow up. The main parameter will be the severity of PTSD symptoms (PTSD Symptoms Scale-Self Report). Secondary outcome variables are the presence of a PTSD diagnosis (Clinician-Administered PTSD Scale for DSM-5), severity of complex PTSD symptoms (Structured Interview for Disorders of Extreme Stress-Revised and symptoms-specific questionnaires), changes in symptoms of general psychopathology (Brief Symptom Inventory), and quality of life (Euroqol-5D). Health care consumption and productivity loss in patients will also be indexed.DiscussionThe study results may help to inform the ongoing debate about whether a phase-based approach has added value over immediate trauma-focused therapy in patients suffering from PTSD due to childhood abuse. Furthermore, the results will contribute to knowledge about the safety, efficacy, and cost-effectiveness of treatments in this target group.Trial registrationNederlands Trialregister, NTR5991 . Registered on 23 august 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5991.

Project description:BackgroundThe optimal time at which to perform a frozen-thawed embryo transfer (FET) following a failed in-vitro fertilization-embryo transfer (IVF-ET) attempt remains elusive to most reproductive experts. Physicians often delay the introduction of FET due to concerns related to potential residual effects of ovarian hyperstimulation which may interfere with the regular menstrual cycle. Moreover, given that most of the published studies on the topic are retrospective and have inconsistent findings, it is crucial to develop evidence-based randomized control guides for clinical practice. Therefore, this well-designed randomized controlled trial (RCT) was conducted to determine whether it is necessary to delay FET for at least one menstrual cycle after the failure of fresh embryo transfer.MethodsInfertile women eligible for IVF-ET were invited to participate in this multicenter, randomized, non-inferiority, parallel-group, unblinded, controlled trial at the academic fertility centers of four public hospitals in Chinese Mainland. Infertile women scheduled to receive their first FET cycle after a failed IVF-ET attempt were randomly assigned to either (a) the immediate FET group in which FET was performed in the first menstrual cycle following the failed IVF-ET cycle (n = 366) or (b) the delayed FET group in which FET was performed in the second or subsequent menstrual cycle following the failed IVF-ET cycle (n = 366). All FET cycles were performed during hormone replacement cycles for endometrial preparation. The primary outcome was the ongoing pregnancy, defined as a detectable fetal heart beat beyond twelve weeks of gestation. Secondary outcomes were other pregnancy-related outcomes, maternal and neonatal complications. Analysis was performed by both intention-to-treat and per-protocol principles.ResultsA total of 646 FETs were completed. The frequency of moderate to severe depression and high stress level prior to FET in delayed FET group were significantly higher than that in immediate FET group (10.6% vs 6.1%, p = 0.039; 30.3% vs 22.4%, p = 0.022, respectively). Immediate FET resulted in a higher frequency of clinical pregnancy than did delayed FET (41.7% vs 34.1%), for a relative risk (RR) of 1.23 (95% confidence interval [CI], 1.00-1.50; p = 0.045). Women who underwent immediate FET also had a lower frequency of biochemical pregnancy loss (11.7% vs. 30.6%), with a RR of 0.28 (95% CI 0.23-0.63, p < 0.001), and a higher frequency of embryo implantation (25.2% vs. 20.2%), with a RR of 1.25 (95% CI 1.01-1.53; p = 0.038). Although the ongoing pregnancy and live birth rates did not differ significantly between the immediate FET and delayed FET groups (37.1% vs 30.3%, RR 1.22, 95% CI 0.99-1.52, p = 0.067; 36.5% vs 30.0%, RR 1.22, 95% CI 0.98-1.52, p = 0.079, respectively), a multivariate logistic regression analysis adjusted for potential confounders such as depression and stress levels revealed that the immediate FET group had a significantly higher ongoing pregnancy and live birth rates than the delayed FET group (odds ratio 0.68, 95% CI 0.47-0.99, p = 0.041; odds ratio 0.67, 95% CI 0.46-0.96, p = 0.031). The risks of maternal and neonatal complications were comparable between the two groups.ConclusionsIn women with a previous failed IVF-ET attempt, immediate FET resulted in higher ongoing pregnancy and live birth rates than delayed FET. These findings warrant caution in the indiscriminate application of a delayed FET strategy when apparent risk of high stress level is perceived.Trial registrationChiCTR2000033313 .

Dataset Information

A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2).

Publications

A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2).

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