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Wounds and Injuries clinical trials

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NCT ID: NCT00945542 Completed - Hemorrhagic Shock Clinical Trials

The Trauma- Formula-Driven Versus Lab-Guided Study (TRFL Study)

TRFL
Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital deaths following trauma. There have been lately several published studies suggesting that higher transfusion ratios of fresh frozen plasma (FFP), platelets (PTL) and cryoprecipitate (CRYO) to red blood cell (RBC) are associated with survival advantages. However, the evidence comes from retrospective data limited by a significant number of unaddressed confounders. In addition, the use of blood products bears known and important risks of complications. Hypothesis: The adoption of a formula-driven transfusion practice with pre-defined ratios of FFP to PTL to RBC transfusion (1:1:1) is feasible and superior to current laboratory-guided transfusion practice in treating and/or preventing early coagulopathy improving survival rates in massively bleeding trauma patients . Objective: To exam the feasibility of implementing a pre-defined ratio of FFP to PTL to RBC (1:1:1) transfusion protocol and its impact on a population of bleeding trauma patients. Design: A two-year pilot feasibility randomized control trial at Sunnybrook Health Sciences Centre. Randomization: 70 patients are expected to be randomized to lab-driven or to formula-driven massive transfusion protocol and followed-up to 28 days or hospital discharge. Study outcomes: protocol violation; in-hospital mortality by exsanguination; death at 28 days; coagulation competence defined by current standard coagulation tests (INR & PTT < 1.5 times normal; PTL ≥ 50 and Fibrinogen ≥ 1.0) or clotting factor levels ≥ 30%; correlation of current standard coagulation tests with clotting factors levels; cessation of bleeding; incidence of ALI, sepsis, MOF, transfusion-related circulatory overload, transfusion reactions; Ventilator-free days; ICU & Hospital LOS; thromboembolic events. Intervention protocol: Transfusion of pre-defined ratios of FFP and PTL to RBC (1:1:1) (formula-driven) for the first 12h of hospitalization without coagulation tests guidance while patient is hemorrhaging or before if bleeding stops. Statistical analysis: protocol compliance rate and in-hospital mortality rates within 24h and at 28 days will be assessed using Chi-square test. ROC analysis will be used to analyze coagulation competence. Main expected outcomes: implementation of a formula-driven transfusion protocol is feasible and coagulation competence will be achieved faster and more efficiently in the study group.

NCT ID: NCT00935428 Completed - Injury Clinical Trials

Causes and Circumstances of Horse Related Injuries and Impact on Quality of Life

Start date: June 2009
Phase:
Study type: Observational

Horse-related activity can be risky. Horses are the leading cause of animal-related fatalities in Oregon and Oregon's annual death rate from animals is 45% higher than the national rate. By interviewing injured equestrians, the investigators may be able to determine patterns of decision-making and behavior from their collective experience and develop useful safety recommendations. The investigators will also determine the impact that the injury has had on quality of life. The long-term goal of the investigators research is to develop safety and prevention recommendations and a horse-related injury prevention program to reduce the number of horse related injuries.

NCT ID: NCT00929045 Completed - Clinical trials for Traumatic Brain Injury

Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development

Start date: July 2007
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.

NCT ID: NCT00919581 Completed - Spinal Cord Injury Clinical Trials

Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury

Start date: May 2009
Phase: N/A
Study type: Observational

The purpose of the study is to investigate inflammatory and other substances that may be elevated in the blood and blood cells following spinal cord injury (SCI). These substances will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first week (acute) or at least one year ago (chronic). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF). MIF is released by cells and has a specific effect on the way cells behave, communicate and work together. In several other medical conditions, MIF is known to increase inflammation in the body. By comparing blood samples from individuals with spinal cord injury and uninjured (no spinal cord injury) individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples to measure other proteins that increase inflammation in the body and to see if the biological activities of MIF can be reduced in a test tube by adding other substances to the blood samples. It is hoped that this study of MIF and other proteins related to inflammation will help improve the treatment of SCI in the future. We hope to enroll a total of 312 subjects in this study (50 with acute spinal cord injury, 125 with chronic spinal cord injury, and 137 uninjured individuals).

NCT ID: NCT00915967 Completed - Clinical trials for Surgical Wound Infections

Prevention of Neurosurgical Wound Infections

POWI
Start date: May 13, 2009
Phase: N/A
Study type: Interventional

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

NCT ID: NCT00890383 Completed - Clinical trials for Abdominal Compartment Syndrome

Colloids in Severe Trauma

CIST
Start date: May 2009
Phase: Phase 4
Study type: Interventional

Background: Fluid resuscitation is a cornerstone of the initial management of the critically injured trauma patient yet there are numerous controversies surrounding this very common practice. As a result, these controversies have been the subject of numerous clinical trials, evidence-based guidelines and systematic reviews. With the publication of the landmark SAFE Study the equipoise between the 2 treatments (which were representative solutions for colloid and crystalloids respectively), 4% albumin and saline, was established. This has however been brought into further doubt by the paucity of data on the use of hydroxyethylstarches (HES), which are less costly and have less side effects than albumin, in trauma. More recent findings by Gruen and colleagues have shown that as much as 5% of all trauma deaths are the result of fluid overload based on the North American fluid management model for trauma (pure crystalloid fluid management). A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with crystalloids is beneficial when given before the onset of organ failure in critically ill surgical patients. Balogh and colleagues found out that when supranormal fuid resuscitation with crystalloids was applied to victims of severe trauma, this resulted in a statistically significant increase in the incidence of mortality, multiple organ failure, intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). More recently, Kirkpatrick and colleagues reviewed and defined a 'secondary' ACS as a direct result of fluid resuscitation. They concluded that "excess resuscitation with crystalloid fluids might be harming patients and contributing to an increased occurrence of ACS." This study will serve as a pilot to test the hypothesis that there will be significant differences in clinical outcomes for patients with severe trauma treated with colloid (HES) plus crystalloid and crystalloid only fluid management regimens, most notably the incidence of IAH and ACS. It is hoped that the hybrid colloid (HES) plus crystalloid fluid management regimen will provide a means to avoid the untoward fluid overload and/or other complications of pure crystalloid fluid management and the costs/complications of albumin administration.

NCT ID: NCT00876889 Completed - Spinal Cord Injury Clinical Trials

Safety of Riluzole in Patients With Acute Spinal Cord Injury

Start date: April 2010
Phase: N/A
Study type: Observational

The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).

NCT ID: NCT00876837 Completed - Clinical trials for Spinal Cord Injuries

Long-term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries

Start date: March 1998
Phase:
Study type: Observational

The purpose of this study is to assess life satisfaction and long-term outcomes (i.e., medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or adolescents.

NCT ID: NCT00876564 Completed - Trauma Clinical Trials

Rogaland Trauma System Study

RTSS
Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.

NCT ID: NCT00869154 Completed - Clinical trials for Traumatic Brain Injury With Brief Loss of Consciousness

Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Start date: March 1, 2009
Phase: N/A
Study type: Interventional

The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor. Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.