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Mgt of Chronic Subdural Hematoma Using Dexamethasone

NCT02938468 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2020-07-01

No results posted yet for this study

Summary

Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.

Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.

Conditions

  • Chronic Subdural Hematoma

Interventions

DRUG

Dexamethasone

PROCEDURE

Any surgical intervention aim at treating chronic subdural hematoma

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-17
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02938468 on ClinicalTrials.gov