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Trauma clinical trials

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NCT ID: NCT02863250 Recruiting - Trauma Clinical Trials

Australian and New Zealand Massive Transfusion Registry

ANZ-MTR
Start date: March 2011
Phase:
Study type: Observational [Patient Registry]

Severe and un-stopped blood loss can occur for a number of different reasons including after a serious injury, delivery of a baby and following other medical and surgical emergencies. The investigators understanding of how to best treat people with serious bleeding is still incomplete, with many questions remaining. These include questions regarding how many people have serious bleeding events, what happens to them and the best way to treat them. The Massive Transfusion Registry (MTR) is a register of patients who have experienced major blood loss that required a massive transfusion in any clinical setting. The MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical data from hospital data sources, including Laboratory Information Systems (for transfusion history and laboratory results) and Health Information Services databases (for Patient demographics and admission data), are electronically extracted by staff employed at the participating hospitals. The data is then sent to the MTR Research Team, located at Monash University, where it is then linked, analysed and stored. The establishment of a Massive Transfusion Registry will be a unique and important resource for clinicians in Australia, New Zealand and internationally, for Blood Services and for the broader community. It will provide valuable observational data regarding the types and frequency of conditions associated with critical bleeding requiring massive transfusion, the use of blood component therapy (i.e. ratios and quantities of different types of red cell to non- red cell components) and patient outcomes.

NCT ID: NCT02857439 Recruiting - Trauma Clinical Trials

Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

CASH
Start date: July 2016
Phase: N/A
Study type: Interventional

What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%? Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries. The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.

NCT ID: NCT02856789 Completed - Trauma Clinical Trials

Determination of Fibrin Activity in Plasma on STA-R® Prototype

FAST
Start date: August 2016
Phase:
Study type: Observational

The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.

NCT ID: NCT02838459 Completed - Trauma Clinical Trials

Can Prediction Models Triage Trauma Patients More Accurately Than Clinicians?

Start date: July 2016
Phase:
Study type: Observational

Using a prospective cohort design, the aim of this study is to compare the performance of clinicians with prediction models in triaging trauma patients.

NCT ID: NCT02773693 Active, not recruiting - Insomnia Clinical Trials

Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)

Start date: August 2016
Phase: N/A
Study type: Interventional

The primary objective of the current study is to determine if providing cognitive-behavioral therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT) results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is to determine if the sequencing of CBTl&N before or after CPT results in differential effects on PTSD and sleep symptom reduction.

NCT ID: NCT02772653 Completed - Trauma Clinical Trials

Evaluation of Resuscitation Markers in Trauma Patients

Start date: May 2016
Phase:
Study type: Observational

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients. This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

NCT ID: NCT02753166 Withdrawn - Trauma Clinical Trials

Dexamethasone as an Immediate Intervention

Start date: January 2017
Phase: Phase 1
Study type: Interventional

To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.

NCT ID: NCT02745041 Completed - Trauma Clinical Trials

Fibrinogen Early In Severe Trauma studY

FEISTY
Start date: December 2016
Phase: Phase 2
Study type: Interventional

- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients - Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma - Hypo/dysfibrinogenaemia plays an important role in TIC - Early replacement of fibrinogen may improve outcomes - Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate - The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP - Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP - It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies - Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence - Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay - No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients - Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm - It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) - Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate - It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible

NCT ID: NCT02737488 Terminated - Trauma Clinical Trials

Helping Children With Trauma

Start date: February 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can include experiencing or witnessing violence, excessive bullying, war, car accident, serious injury, getting mistreated or anything else that makes one feel scared or frightened. Children/teens who experience traumatic events have been shown to be at higher risk of poor mental and physical health. Trauma can impact family life, school life and interpersonal relationships well into adulthood. Unfortunately, most children who have experienced traumatic events do not undergo treatment. Although promising treatments do exist, most do not address the complexity of trauma, particularly related to ongoing stress and threats to safety in their environments. One hundred and twenty eligible youth will be randomized to receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual (TAU) at a community mental health clinic. It is hypothesized that: - Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to youth receiving treatment as usual (TAU) in the community. - Youth receiving TST will demonstrate a greater decrease in symptoms of depression, anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.) at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU. - Youth receiving TST will have fewer acute mental health service events, such as psychiatric hospitalizations and ED visits compared to youth receiving TAU. - Greater fidelity to the TST model is associated with better treatment outcomes among youth receiving TST.

NCT ID: NCT02691650 Completed - Trauma Clinical Trials

Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma

POCCET
Start date: February 2016
Phase:
Study type: Observational

Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.