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Cerebral Hemorrhage clinical trials

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NCT ID: NCT06383741 Recruiting - Clinical trials for Intra Cerebral Hemorrhage

Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors

FIRE-Xa
Start date: July 10, 2023
Phase:
Study type: Observational

This study focuses on direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and the thrombin inhibitor dabigatran, commonly used for stroke prevention in atrial fibrillation. Despite lower intracranial bleeding risks with these drugs, around 0.2-1.0% of patients annually experience intracranial hemorrhage (ICH), predominantly intracerebral. Treatment options for factor-Xa inhibitor-associated ICH, such as prothrombin complex concentrate (PCC) and andexanet alfa, lack direct comparison evidence except for ongoing trials like ANNEXA-I. This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activity's role and long-term effects, especially in patients presenting late after drug intake. The measurement of anti-FXa levels helps guide decisions, yet their link to hematoma expansion remains unknown. Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels, with some patients exhibiting high levels even beyond 12 hours post-intake. This lack of data poses challenges, particularly for patients potentially benefiting from treatment beyond the current strict time window. Early hematoma expansion strongly predicts poor outcomes, but preventing it faces challenges like recurrent events (up to 5% by 3 months) and rehabilitation intensity, potentially negating its benefits. The ANNEXA-I trial evaluates short-term outcomes, highlighting the need for additional data to comprehend long-term ICH prognosis. The study's objectives involve linking hematoma expansion to anti-FXa levels, determining late-presenting patients' risk of expansion, and identifying predictors of favorable outcomes at 3, 6, and 12 months. Primary endpoints include functional outcomes, while secondary ones encompass expansion rates, anticoagulant activity, and various events at 12 months. This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH, addressing both immediate and prolonged outcomes to enhance clinical decision-making.

NCT ID: NCT06361433 Recruiting - Clinical trials for Intracerebral Hemorrhage

Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage

RAINBOW-Hx
Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are: - The safety of the product - The efficacy of the product

NCT ID: NCT06353555 Recruiting - Clinical trials for Intracerebral Hemorrhage

Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage

Start date: October 11, 2023
Phase: N/A
Study type: Interventional

Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients. Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established. As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism. The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial. This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism.

NCT ID: NCT06282029 Recruiting - Stroke Clinical Trials

ACT-group for Stroke Survivors (Pilot Study)

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are: - Is the group therapy feasible? - Is the group therapy accepted by stroke survivors and therapists? - Are there first indications on the efficacy of the group therapy to improve mental health? Participants will take part in 8 weekly group therapy sessions of 90 minutes each.

NCT ID: NCT06255977 Recruiting - Clinical trials for Intracerebral Hemorrhage

A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral Hemorrhage

Start date: August 24, 2022
Phase: Phase 2
Study type: Interventional

Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses. We developed a 5-amino acid peptide, CN-105, that mimics the polar face of the apoE helical domain involved in receptor interactions, readily crosses the blood-brain barrier, and improves outcomes in well-established preclinical ICH models. In the current study, aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages.

NCT ID: NCT06255353 Recruiting - Clinical trials for Intracerebral Hemorrhage

Effect of Different Feeding Modes in Intracerebral Hemorrhage

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are: Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer. Participants will be divided into two groups randomly, with different nutritional support respectively.

NCT ID: NCT06221215 Recruiting - Clinical trials for Brain Injury Traumatic Diffuse With Loss of Consciousness

Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

Our understanding of neurosecretory dysfunction after TBI is still insufficient, and the number of patients with neuroendocrine dysfunction caused by craniocerebral trauma may be underestimated, especially the neuroendocrine changes related to HPA axis in the early stage after craniocerebral trauma. Moreover, there are few and fragmentary literature data on the benefits of hormone replacement therapy in patients with neuroendocrine disorders after traumatic brain injury. This requires more studies to further determine the characteristics of pituitary function or hormone disorders in the early stage after traumatic brain injury, which makes it necessary for us to further study the neuroendocrine dysfunction (hormone disorder) in the early stage after craniocerebral injury. To explore the relationship between craniocerebral injury and early hormone disorder by measuring the changes of early hormone levels in patients with TBI is of great significance for the early detection of related complications after craniocerebral injury and the evaluation of the prognosis of patients with craniocerebral injury, and can provide a new diagnosis and treatment plan for early intervention of related complications after TBI.

NCT ID: NCT06101537 Recruiting - Clinical trials for Subarachnoid Hemorrhage

Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

MERCURY
Start date: February 15, 2024
Phase:
Study type: Observational

The goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.

NCT ID: NCT06078020 Recruiting - Cerebral Hemorrhage Clinical Trials

PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study

PLINTH
Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to answer three uncertainties about the design of a platform study for adults with stroke due to intracerebral haemorrhage. The main things the investigators aim to find out are: - The acceptability of a platform trial and its comparisons to brain haemorrhage survivors or their carers, and their clinicians. - Estimates of eligibility, willingness to participate, diversity, representativeness, adherence, retention, data completion, and event rates of intermediate and clinical outcomes over time for each comparison. - The most efficient platform trial design considering the findings of this feasibility study. Participants, or their welfare guardian, welfare attorney, or nearest relative will: - Watch a video informing them about the study - Read written information about the study - Provide informed consent - Permit collection of demographic and clinical details - Provide information in interviews at ~3 and ~14 days after the onset of the stroke

NCT ID: NCT06067750 Recruiting - Clinical trials for Traumatic Brain Injury

Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation

Start date: June 27, 2023
Phase:
Study type: Observational

A study in the use of the Narcotrend depth of anaesthesia monitor to record a) seizures, and b) monitor a level of sedation referred to as 'burst suppression', in sedated patients in the adult and paediatric intensive care. Studies have shown that patients in coma on the intensive care unit may have subclinical in addition to clinical seizures. Subclinical seizures are seizures that do not show any outward signs and may go undetected. The current gold standard of recording seizures in the intensive care unit is by non-invasive, continuous monitoring of the electrical activity of the brain by electroencephalography (cEEG) using cerebral function analysing monitor (CFAM). This is recorded with simultaneous video recording and is performed by Clinical Neurophysiology departments. There has been a steady increase in demand for this service over recent years. Additionally, CFAM / cEEG is labour intensive and expensive. If trends continue, the proportion of hospitals offering CFAM / cEEG will continue to rise, creating increased demand for specialist staff, of which there are a finite number. Depth of anaesthesia monitors are used by anaesthetists to assess the level of anaesthesia in sedated patients using specialised, automated EEG analysis and are now recommended by NICE (DG6) to tailor anaesthetic dose to individual patients. This study aims to investigate the utility of the Narcotrend depth of anaesthesia monitor to monitor for seizures and burst suppression on the adult and paediatric intensive care unit. These monitors are cheaper and more widely available with the scope to be used at every bed space requiring neuro observation on the intensive care unit. The study aims to recruit all patients who are referred for CFAM / cEEG monitoring at Nottingham University Hospitals (NUH) Trust over a 12 month period. These patients will undergo simultaneous recording using CFAM / cEEG and depth of anaesthesia monitoring.