CSF Drain Placement for Aortic Aneurysm

No longer recruiting at 2 trial locations

Overseen By Rebecca St. John

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Active incarceration, Pregnancy, Moribund, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether placing a cerebrospinal fluid (CSF) drain before a specific type of aortic surgery can reduce the risk of spinal cord issues. It focuses on patients undergoing endovascular thoracoabdominal aneurysm repair, a procedure for treating large aortic bulges. The study investigates two approaches: some patients will receive a CSF drain before surgery, while others will receive it only if needed afterward. Suitable candidates for this trial are those scheduled for high-risk endovascular repair involving significant aortic coverage. As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cerebrospinal fluid drain placement is safe for aortic aneurysm patients?

Research has shown that placing a cerebrospinal fluid (CSF) drain as a preventive measure is generally well-tolerated by patients. In one study, complications occurred in about 9.6% of cases, with only a small portion (0.74%) being serious. A review of over 1,400 patients found the procedure mostly safe, though it carries some risks.

Rare issues include bloody taps, which can delay surgery, blockages in the catheter, and bleeding in the spine. However, these problems are uncommon.

Overall, while some risks exist, the procedure is generally safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether placing a cerebrospinal fluid (CSF) drain before endovascular aortic repair can make a difference in preventing spinal cord ischemia. Typically, patients only receive a CSF drain after surgery if symptoms of spinal cord ischemia appear. This study aims to find out if a proactive approach with a prophylactic CSF drain could reduce the risk of complications, offering a potential improvement over the current reactive standard of care. By investigating this method, researchers hope to enhance patient outcomes by preventing issues rather than just treating them after they occur.

What evidence suggests that cerebrospinal fluid drain placement is effective for preventing spinal cord ischemia?

Research suggests that a preventive cerebrospinal fluid (CSF) drain might lower the risk of spinal cord ischemia (SCI), a condition where the spinal cord doesn't receive enough blood. In this trial, participants in the experimental arm will receive a prophylactic CSF drain placement before their endovascular aortic repair. One study showed that using CSF drainage beforehand reduced the chances of paraplegia (paralysis of the legs and lower body) after aneurysm repair. However, a review of multiple studies found no significant difference in SCI rates when using CSF drainage preventively compared to not using it. Participants in the control arm will not receive a prophylactic CSF drain but may receive one post-operatively as needed. The benefit appears most noticeable in high-risk patients, such as those with previous aortic aneurysm repairs. Overall, while some positive evidence exists, the effectiveness of preventive CSF drains is not yet fully confirmed. ^{3 4 6 7 8}

Who Is on the Research Team?

Adam Beck, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am having surgery for a major aortic aneurysm.

Exclusion Criteria

I have had a ruptured aneurysm.

I need or have had an urgent surgery for an aneurysm.

Currently in jail.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular thoracoabdominal aortic aneurysm repair with either prophylactic or selective cerebrospinal fluid drain placement

1 week

1 visit (in-person)

Follow-up

Participants are monitored for the onset of spinal cord ischemia and other complications post-operatively

1 year

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Cerebrospinal Fluid Drain Placement

Trial Overview 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.

How Is the Trial Designed?

Group I: Prophylactic cerebrospinal fluid drain placement Experimental Treatment 1 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 placement Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Citations

1. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00429-4/fulltext

Prospective randomized pilot trial comparing prophylactic ... Within the prophylactic drainage cohort, there was a 100% success rate for preoperative prophylactic spinal drain placement. Although there were ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04941157?cond=%22Spinal%20Cord%20Ischemia%22&viewType=Table&rank=1

Prophylactic vs Therapeutic Cerebrospinal Fluid Drain ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078588423003672

Systematic Review of the Effect of Cerebrospinal Fluid ... The analysis showed no significant difference in SCI rate when CSF drainage was used prophylactically compared with no use of CSF both in endovascular DTAA and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5594124/

Effects of preemptive cerebrospinal fluid drainage on ... Cerebrospinal fluid drainage reduces paraplegia after thoracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg 2002;35 ...

5. jcvaonline.com jcvaonline.com/article/S1053-0770(18)30107-1/fulltext

Prophylactic Cerebrospinal Fluid Drainage for High-Risk ... They were also able to show that the benefit of CSF drainage was greatest in patients at a higher risk for spinal cord injury such as previous AAA repair, more ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12095451/

Safety and validity of selective cerebrospinal fluid drainage ... Drainage-related complications were observed in 13 (9.6%), one of which was graded severe (0.74%). In patients undergoing prophylactic drainage, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0741521425010924

A report of the safety of prophylactic spinal fluid drainage in ... The objective of this retrospective study was to review the risks of prophylactic SFD in 1445 patients undergoing open and endovascular TAA and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772687823000132

Safety and efficacy of fluoroscopically guided ... There were 4 major complications (2 bloody taps causing a delay in surgery, 1 catheter occlusion, and 1 symptomatic spinal hematoma) and 2 minor complications ( ...