Clinical Research Directory

Blood Storage Related Mortality and Adverse Effects in Trauma Patients

The purpose of this retrospective study is to examine the following factors related to blood storage time in severely injured trauma patients who received large blood transfusions: 1. The effect of blood storage time on the patient's 28-day mortality rate. 2. The relationship between storage time and other health problems that the patient may develop (such as heart disease, vascular occlusion, respiratory failure, infection, and organ failure). For this purpose, patients aged 18-75 who were admitted directly from the scene of injury and received large transfusions at Jacksonville Shands Hospital between January 1, 2023, and October 1, 2025, will be included. Data will be obtained from hospital information systems and anesthesia records

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

The NRC Dataset. Developing a Minimum Dataset for Multidisciplinary Rehabilitation: a Modified E-Delphi Study

Several rehabilitation datasets are presently in use for specific patient groups in England. The 'National Clinical Audit of Specialist Rehabilitation for patients with complex needs following major injury' (NCASRI) evaluated outcomes within a cohort of Major Trauma patients between 2015 and 2018 using data from two of these datasets. The NCASRI project outlined some of the shortcomings of the pre-existing datasets and highlighted the need for a single National Rehabilitation Dataset to provide long term evaluation of a variety of patient presentations. The proposed study will seek to develop such a dataset by means of an E-delphi study. This study will seek consensus from a panel of experts on the data items required to measure the effectiveness and socio-economic impact of multidisciplinary inpatient rehabilitation. Providing commissioners, researchers and clinicians with the data required to improve patient care, conduct research and develop rehabilitation services. There are three potential phases to this study: * Phase one involves the establishment of a core domain set, outlining what information (data) should be included in the NRC core dataset. * Phase one will consist of at least 2 rounds of voting, with successive rounds of voting undertaken until an a-priori consensus of 70% is reached for all core data items marked as mandatory/critical data in fitting OMERACT guidelines. * After 2 rounds, any data item that have reached consensus will be included in the final dataset. These core domain (data items) will then be excluded from subsequent rounds of voting. * A maximum of 4 rounds will be allowed in Phase 1. At which point the highest-ranking data items remaining with a consensus above 60% from each of the pre-identified categories will be included in the final dataset. * Phase two will explore what tools should be used to collect the core domains (outcome measure instruments) for each category outlined in phase 1. * Phase 2 will follow the same protocol for including outcome measure instruments into the core outcome set as were required to include core data items from phase 1. * If a consensus of equal or greater than 60% cannot be reached using an E-Delphi method in either phase 1 or phase 2 then a virtual meeting will be held amongst all expert panel members to reach consensus using a nominal group technique (phase 3).

Arterial Line in Trauma Resuscitation

Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring. With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown. The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.

Vitamin D for Critically Traumatic Patients

Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients. The serum levels of calcidiol and PTH will be measured on Day 0, Day 3, Day 10, Day 15, Day 30 and Day 60 before and after vitamin D supplementation.

Enhanced Rehabilitation After Major Trauma (PROPERLY)

The goal of this study is to assess the feasibility of recruitment, and barriers to delivery of an enhanced rehabilitation service, in patients surviving major trauma. The main questions it aims to answer are: are the investigators able to recruit patients to a research study are the investigators able to retain patients in the research study are the investigators able to identify appropriate primary outcome measures are the investigators able to identify barriers to future large-scale definitive trial or service delivery Participants will would be offered at least two sessions of the Enhanced Rehabilitation Programme (ERP), each lasting 60-120 minutes per week, delivered in the Manchester Institute of Health and Performance (MIHP). Participants not willing to travel to the MIHP, or declining to engage in the ERP, will be asked to join the Standard Care (SC) group. This group will provide questionnaire data and clinical outcome measure collection with their usual place of therapy. Researchers will compare the ERP group and the SC groups to assess any additional benefits to the ERP.

Shock and Acute Conditions OutcOmes Platform

In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%). Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention. To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials. This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature).