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Trauma clinical trials

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NCT ID: NCT03005418 Active, not recruiting - Trauma Clinical Trials

Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

Start date: September 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.

NCT ID: NCT02999386 Completed - Diabetes Mellitus Clinical Trials

Stress Induced Hyperglycemia In Trauma

SIHG
Start date: October 2016
Phase:
Study type: Observational

The clinical relevance of the observed stress induced hyperglycemia in trauma patients remains unclear. The earlier studies suggested the implications of cytokines in stress induced hyperglycemia and the outcomes after trauma. To date, there is little information available regarding the effect of diabetic hyperglycemia (occult or known) on outcomes after trauma and whether these patients represent a distinct group with differential outcomes when compared to those with stress-induced hyperglycemia. Herein, the purpose of this study is to identify the incidence of stress induced hyperglycemia as well as diabetic hyperglycemia in trauma patients and to investigate the association between proinflammatory cytokine levels and hyperglycemia in our trauma population.

NCT ID: NCT02984384 Completed - Trauma Clinical Trials

PREVENTion of Clot in Orthopaedic Trauma

PREVENT CLOT
Start date: April 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.

NCT ID: NCT02963233 Recruiting - Trauma Clinical Trials

Type II Pediatric Supracondylar Humerus Fracture Management and Outcomes: A Prospective Multi-centre Cohort Study

Start date: July 2015
Phase: N/A
Study type: Observational

The treatment of pediatric supracondylar humerus fractures is controversial, but despite the injury's high incidence there is a lack of high level evidence to guide operative versus non-operative decision making for displaced fractures with an intact posterior cortex (Gartland Type II). This study aims to prospectively compare clinical, functional, and radiographic outcomes between operatively and non-operatively treated patients using a prospective multi-centre cohort design.

NCT ID: NCT02926274 Active, not recruiting - Trauma Clinical Trials

Transfusion Using Stored Whole Blood

Start date: October 18, 2017
Phase: N/A
Study type: Observational

Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Reconstituted whole blood, or component therapy with packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of high plasma volumes may be associated with increased risk of allergic reaction, transfusion associated acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress syndrome (ARDS). Military services have recently reintroduced fresh whole blood (WB) for standard resuscitation of massive hemorrhage, have found that WB offers a survival advantage over component therapy, and that risks of transfusion reactions are similar for WB and PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in pediatric open heart surgery and autologous blood donation but is no longer commonly available for other indications. However, the military results are renewing interest in whole blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a platelet-sparing filter was recently approved by the University of California Los Angeles Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients. This study will test the feasibility of providing stored WB for resuscitation of patients in hemorrhagic shock and determine the effects of WB on clinical outcomes as well as the effects on coagulation, fibrinolysis, and inflammation, compared to standard blood component therapy.

NCT ID: NCT02897505 Withdrawn - Trauma Clinical Trials

Music Workshops in the EMPOWER Clinic

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

Women will be recruited from the EMPOWER clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find out about the music workshops and the study through Sanctuary for Families staff, who will post flyers in their noticeboards or offices. This study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence. Assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.

NCT ID: NCT02880163 Not yet recruiting - Trauma Clinical Trials

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

REVIVE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.

NCT ID: NCT02877875 Completed - Depression Clinical Trials

Student Outcomes of Integrative Mental Health Services

Start date: January 2015
Phase: N/A
Study type: Interventional

The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.

NCT ID: NCT02872428 Terminated - Trauma Clinical Trials

A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)

Start date: November 2016
Phase: Phase 1
Study type: Interventional

THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects. ID: VPA-C-002 The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.

NCT ID: NCT02864875 Completed - Trauma Clinical Trials

Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

Start date: December 2015
Phase: Phase 4
Study type: Interventional

This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.