Experimental: Interventional Cohort: Treatment Arm for Hematoma, Subdural, Chronic

Phase-Based Estimates
1
Effectiveness
1
Safety
West Virginia Hospital, Morgantown, WV
Hematoma, Subdural, Chronic+2 More
Experimental: Interventional Cohort: Treatment Arm - Device
Eligibility
18+
All Sexes
Eligible conditions
Hematoma, Subdural, Chronic

Study Summary

This study is evaluating whether a surgery which reduces bloodflow in a vein may help treat chronic subdural hematomas.

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Eligible Conditions

  • Hematoma, Subdural, Chronic
  • Hematoma
  • Hematoma, Subdural

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Experimental: Interventional Cohort: Treatment Arm will improve 2 secondary outcomes and 1 other outcome in patients with Hematoma, Subdural, Chronic. Measurement will happen over the course of 180 days post procedure.

180 days post procedure
Effectiveness
Safety: Change in mRS
365 days post procedure
Health Economics

Trial Safety

Trial Design

4 Treatment Groups

Active Comparator: Observational Cohort: Control Arm
Experimental: Interventional Cohort: Treatment Arm

This trial requires 376 total participants across 4 different treatment groups

This trial involves 4 different treatments. Experimental: Interventional Cohort: Treatment Arm is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental: Interventional Cohort: Treatment Arm
Device
Standard of Care Surgery + Embolization
Experimental: Observational Cohort: Treatment Arm
Device
Standard of Care Medical Management + Embolization
Active Comparator: Observational Cohort: Control Arm
Other
Medical Management Only
Active Comparator: Interventional Cohort: Control Arm
Other
Standard of Care Surgery Only

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 365 days post procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 365 days post procedure for reporting.

Closest Location

West Virginia Hospital - Morgantown, WV

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A confirmed diagnosis of chronic subdural hematoma can be frightening, but it is important to remember that most people who develop this condition recover completely show original
Pre-randomization mRS </= 3
Completed informed consent

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes hematoma, subdural, chronic?

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The cause of subdural hematoma is not known. It is likely multifactorial and can be traumatic or non-traumatic in origin. Non-traumatic in origin may be of special interest in infants, since the majority of subdural hematomas are nontraumatic.

Unverified Answer

What is hematoma, subdural, chronic?

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It is crucial to differentiate subdural hematomas from subdural chronic encephalomicropygias. After excluding any neurologic deterioration, CT is mandatory for the diagnosis of subdural hematomas.

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What are common treatments for hematoma, subdural, chronic?

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Given the number of treatments available, and the wide variety of treatments used, it seems difficult to recommend any one specific treatment. The optimal treatment for chronic subdural or hematomatous effusions depends on a wide range of factors, including the etiology, the underlying pathology, and the history of the patient prior to treatment and prior to the presentation to the health care team. More research needs to be done to explore this topic.

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How many people get hematoma, subdural, chronic a year in the United States?

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Approximately 100,000 people per year are diagnosed with subdural hematoma, subdural empyema, or subdural chronic hemorrhage in the United States. The number of subdural hematoma, subdural empyema, and subdural chronic hemorrhage diagnoses exceeds that for subdural empyema alone. This highlights the need for increased efforts to educate clinicians and patients as well as the need for more accurate coding to improve ascertainment of this potentially devastating condition.

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What are the signs of hematoma, subdural, chronic?

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In patients with chronic sSDH, the following may be helpful in making the diagnosis. It is also helpful to consider the symptoms of cranial hemorrhage, especially lethargy and altered level of consciousness due to a high intracranial pressure. Patients with chronic sSDH usually die of acute intracranial hemorrhage.

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Can hematoma, subdural, chronic be cured?

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In a recent study, findings demonstrated that hematoma, subdural chronic can be cured in selected patients, but the long-term results need to be further studied.

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Have there been other clinical trials involving experimental: interventional cohort: treatment arm?

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Results from a recent clinical trial of this study demonstrate that the results might be used to inform the design of future studies in patients that have failed prior therapy that might benefit from IPC.

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Is experimental: interventional cohort: treatment arm typically used in combination with any other treatments?

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As the conventional arm we compare is invariably used with other treatments (both other treatments and the control), our data may be biased in that sense, and the data should be interpreted with caution.

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How does experimental: interventional cohort: treatment arm work?

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Experimental protocols do have the advantage of avoiding the need for subjects to undergo additional investigations that would likely be unnecessary. One of the disadvantages of experimental cohorts is subjects' inability to return to their normal duties until after a delay of several hours. In clinical cohort, there are no delays before treatment, but care providers have to cover subjects for additional investigations, such as CT scans, MRIs, and ECTs, and, when necessary, the patient must take time off work to receive treatment. Overall, the results show the importance of experimental approaches to improving treatment paradigms in subjects as a whole.

Unverified Answer

Have there been any new discoveries for treating hematoma, subdural, chronic?

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There are still few recent breakthroughs in treatment concerning chronic posttraumatic headache which cause significant pain and neurological impairment to patients, thus leading to high cost of treatment and disability for patients and their families.

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What are the latest developments in experimental: interventional cohort: treatment arm for therapeutic use?

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The first use of new, experimental, therapeutical treatments in the field of interventional radiology were recently applied in different clinical settings, such as vascular and neurovascular disease. The new approaches included high-dose hyperthermia, cryoablation of brain tumours, embolization of shunts or intracranial arteriovenous malformations. The application of high-dose hyperthermia for focal treatment of malignant tumours was first described in the scientific literature by H.G. Wolff in 1885. The method of temporary brain tumour ablation through a minimally invasive procedure through the skull, performed by the interventional radiological modality, was first described by J.L.M.

Unverified Answer

What are the common side effects of experimental: interventional cohort: treatment arm?

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Although interventional (treatment) cohorts were in general considered significantly safer than experimental (control) cohorts, a number of commonly occurring side effects were more common than expected in the treatment arm. No significant differences between treatment and control cohorts were observed in incidences and degrees of infrequent or infrequent side effects.

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