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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04521881 Recruiting - Clinical trials for Traumatic Brain Injury

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

CRASH-4
Start date: April 18, 2021
Phase: Phase 3
Study type: Interventional

Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury

NCT ID: NCT04508244 Recruiting - Trauma Clinical Trials

Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status

BBTBBT
Start date: December 29, 2020
Phase: Phase 4
Study type: Interventional

Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients. Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.

NCT ID: NCT04499755 Recruiting - Brain Injuries Clinical Trials

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Start date: June 1, 2020
Phase: Phase 3
Study type: Interventional

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

NCT ID: NCT04489160 Recruiting - Clinical trials for Traumatic Brain Injury

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury

CIAO@TBI
Start date: February 25, 2021
Phase: Phase 2
Study type: Interventional

Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.

NCT ID: NCT04487275 Recruiting - Clinical trials for Traumatic Brain Injury

MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)

MLC901
Start date: August 20, 2018
Phase: Phase 4
Study type: Interventional

Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.

NCT ID: NCT04462549 Recruiting - Clinical trials for Traumatic Brain Injury

Improving Health Outcomes With Resource Facilitation

ACL
Start date: January 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this research is to test a service the investigators of the study believe may increase quality of life after brain injury and reduce the level of disability that might be associated with that injury. This intervention is called "Resource Facilitation" and involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and will work with participants to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. If randomly assigned to the Resource Facilitation group, participants will receive Resource Facilitation free of charge. If not, they will be assigned to a control group and will not receive the intervention. However, both groups will receive calls every three months. During these calls, a research assistant will collect data about each participant's recovery and progress. If assigned to the Resource Facilitation group, participants may also receive study information in the mail if research assistants are unable to reach participants via telephone.

NCT ID: NCT04459806 Recruiting - Clinical trials for Traumatic Brain Injury

Intracranial PrEssure Time dOse (ImPETO)

ImPETO
Start date: November 13, 2023
Phase:
Study type: Observational

The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting. Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.

NCT ID: NCT04445649 Recruiting - Stroke Clinical Trials

Prognostic Factors to Regain Consciousness

Start date: June 15, 2020
Phase:
Study type: Observational

The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation. In this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.

NCT ID: NCT04442971 Recruiting - Clinical trials for Traumatic Brain Injury

Effectiveness of Music Therapy on Level of Consciousness

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.

NCT ID: NCT04430504 Recruiting - Clinical trials for Traumatic Brain Injury

Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..