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Hematoma clinical trials

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NCT ID: NCT06364059 Not yet recruiting - Clinical trials for Acquired Brain Injury

A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma

Start date: May 2024
Phase:
Study type: Observational

Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes.

NCT ID: NCT06347796 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

CHESS
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: - Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? - What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: - Share their medical history and undergo physical examinations - Have blood drawn - Have CT scans of the head - Answer questionnaires - Undergo MMAE or conventional open surgery - Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

NCT ID: NCT06339983 Not yet recruiting - Clinical trials for Cesarean Section; Complications, Wound, Hematoma

Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar

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

Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29.

NCT ID: NCT06332118 Not yet recruiting - Clinical trials for Hemodialysis Complication

The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured.

NCT ID: NCT06323434 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

Spinal CSF Leaks in Chronic Subdural Hematoma

SPICE
Start date: April 2024
Phase:
Study type: Observational

Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population. The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks. Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH. Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures.

NCT ID: NCT06292585 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)

Start date: March 2024
Phase: N/A
Study type: Interventional

A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.

NCT ID: NCT06274580 Not yet recruiting - Clinical trials for Subdural Hematoma, Chronic

Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms

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

Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.

NCT ID: NCT06163547 Not yet recruiting - Clinical trials for Chronic Subdural Hematomas

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

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

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

NCT ID: NCT06127615 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

The Efficacy of the Longeviti ClearFit Implant in Craniectomies for Post-Operative Monitoring in Chronic Subdural Hematomas

Start date: November 2023
Phase: N/A
Study type: Interventional

Chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. At the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. However, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. Therefore, these patients require multiple repeated CT head images during their inpatient and post-operative follow-up course. This leads to high radiation doses to patients and high-cost burden. The Longeviti ClearFit Cover was developed to allow for ultrasound imaging through the implanted cover. The skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. Using ultrasound would remove the need for high radiation doses with CT, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. This ClearFit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. The aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the Longeviti ClearFit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. This will allow us to determine if this new implant results in reduced need for repeated CT imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.

NCT ID: NCT06119932 Not yet recruiting - Subdural Hematoma Clinical Trials

Evaluation of One Burr Hole Evacuation for Subdural Hematoma

Start date: November 1, 2023
Phase:
Study type: Observational

To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole