UnknownNot Applicable

Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence

United States35 participantsStarted 2019-01-17

Plain-language summary

This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of chronic subdural hematoma (based on imaging) * Need for surgical intervention (assessed by attending neurosurgeon based on full neurological assessment) * The procedure of choice is burr hole drainage * Cessation of anti-coagulant therapy with accompanying normal lab values in appropriate time frames respective to the drug * Tolerance of supine position Exclusion Criteria: * \<60 years old * Presence of acute hemorrhage, stroke, or parenchymal damage * Neurological deficits not accountable to mass effect * Hyponatremia or inherent electrolyte imbalances * Pregnancy or non-consentable patients * Previous neurological surgery up to 1 year before being considered for the study * Rapid re-expansion of brain observed intraoperatively by attending neurosurgeon * Congestive heart failure or other medical conditions precluding normal postoperative administration of IV fluids * Blood glucose levels \> 135 mg/dL

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence Rate

Timeframe: Within 120 days (+/- 7 days) of their initial burr-hole surgery.

Trial details

NCT IDNCT03831997

SponsorCarilion Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-01-01

Contact for this trial

Eric A Marvin, DO

5405889711 eamarvin@carilionclinic.org

View on ClinicalTrials.gov More Chronic Subdural Hematoma trials