CSF Drain Placement for Aortic Aneurysm

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if using CSF drains before surgery can prevent spinal cord injury in patients having endovascular thoracoabdominal aneurysm repair. The study focuses on patients at risk of spinal cord injury due to reduced blood flow during the procedure. CSF drains help by lowering pressure around the spinal cord, improving blood flow and potentially preventing injury. CSF drainage has been used to protect the spinal cord during thoracic and thoracoabdominal aortic surgeries by reducing the risk of paraplegia.

Research Team

Adam Beck, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+