20 Participants Needed

CSF Drain Placement for Aortic Aneurysm

Recruiting at 2 trial locations
RS
Overseen ByRebecca St. John
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 W. Beck, MD - Professor and ...

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 18 years old or older.
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.
See 3 more

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 OverviewThe 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
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.

Find a Clinic Near You

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+