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CSF Drain Placement for Aortic Aneurysm

N/A

Waitlist Available

Led By Adam W Beck, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18

Undergoing high risk endovascular thoraco-abdominal aortic aneurysm repair, based on aortic coverage length: 2a: Extent I, II, III TAAA 2b: Extent IV TAAA with >5cm coverage above the celiac artery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year

Awards & highlights

Study Summary

This trial will compare the occurrence of spinal cord ischemia in patients who do and do not have prophylactic cerebrospinal fluid drains placed before surgery for endovascular thoracoabdominal aneurysm repair.

Who is the study for?

This trial is for adults over 18 who are undergoing a high-risk procedure to repair an extensive thoracoabdominal aortic aneurysm. It's not for those in prison, pregnant, extremely ill ('moribund'), with ruptured aneurysms, needing urgent repairs, or with blood clotting issues that prevent safe placement of a CSF drain.Check my eligibility

What is being tested?

The study tests if placing cerebrospinal fluid drains before the surgery (prophylactic) can reduce spinal cord damage compared to not placing them preemptively. This pilot will set up procedures for a larger future study and is happening at UAB and University of Massachusetts.See study design

What are the potential side effects?

Potential side effects may include risks associated with CSF drain placement such as infection, bleeding around the brain or spine due to puncture (hematoma), headache from low spinal fluid pressure, and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am having surgery for a major aortic aneurysm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Spinal Cord Ischemia Onset

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic cerebrospinal fluid drain placementExperimental Treatment1 Intervention

Patients randomized to receive the experimental treatment will have a prophylactic cerebrospinal fluid drain placed prior to their endovascular aortic repair. All components of the endovascular aortic repair are standard of care treatments.

Group II: Selective cerebrospinal fluid drain placementActive Control1 Intervention

Patients randomized to the control arm of the study will not receive a prophylactic cerebrospinal fluid drain prior to their endovascular aortic repair. Patients will receive a CSF drain post-operative as needed to treat any symptoms of spinal cord ischemia. This arm of the study is current standard of care.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,024 Total Patients Enrolled

University of Massachusetts, WorcesterOTHER

342 Previous Clinical Trials

976,590 Total Patients Enrolled

The University of Texas Health Science Center, HoustonOTHER

903 Previous Clinical Trials

320,957 Total Patients Enrolled

Media Library

Cerebrospinal Fluid Drain Placement Clinical Trial Eligibility Overview. Trial Name: NCT04941157 — N/A

Spinal Cord Ischemia Research Study Groups: Selective cerebrospinal fluid drain placement, Prophylactic cerebrospinal fluid drain placement

Spinal Cord Ischemia Clinical Trial 2023: Cerebrospinal Fluid Drain Placement Highlights & Side Effects. Trial Name: NCT04941157 — N/A

Cerebrospinal Fluid Drain Placement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04941157 — N/A

Frequently Asked Questions

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

For what types of individuals is this research protocol appropriate?

"This clinical trial is enrolling 20 individuals aged between 18 and 100 who are suffering from spinal cord ischemia. Essentialy, the patient must be of a minimum age with evidence of Type I, II, or III thoracoabdominal aneurysm (TAAA) OR they must have more than 5cm coverage above the celiac artery in conjunction with a Type IV TAAA."

Answered by AI

Is geriatric enrollment being accepted for this clinical trial?

"This clinical trial is recruiting individuals who are 18 years or older, and younger than 100."

Answered by AI

Are there available places in this research trial for participants?

"Information found on clinicaltrials.gov confirms that this particular trial is no longer enrolling patients, with the last update occurring on June 2nd 2022. While the study has concluded its recruitment phase, 556 other trials are actively recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair

Adam W Beck 2022. "Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04941157.

All > Abdominal Aortic Aneurysm