What side effects are associated with this type of intervention?

Prophylactic cerebrospinal fluid (CSF) drainage, used to reduce spinal cord pressure and prevent ischemia, is associated with several potential side effects. These include the risk of paraplegia, paraparesis, and epidural hematoma. Additionally, there is a risk of cerebrovascular ischemia, such as embolic strokes, and silent cerebral embolization, which may occur without immediate symptoms but could have long-term effects. These complications highlight the need for careful monitoring and management during and after the procedure.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments directly targeting spinal cord ischemia through methods similar to prophylactic cerebrospinal fluid (CSF) drains. However, the use of CSF drainage to reduce spinal cord pressure and prevent ischemia is a recognized approach in managing conditions like thoracoabdominal aortic aneurysm repair. This method aims to mitigate the risk of spinal cord injury by maintaining adequate spinal cord perfusion. Other related treatments may include the use of neuroprotective agents and careful perioperative management to prevent hypotension and ensure adequate blood flow to the spinal cord.

What other types of research exist?

Promising novel alternatives to prophylactic CSF drains for preventing spinal cord ischemia include the use of advanced neuromonitoring techniques to detect early signs of spinal cord distress, and the administration of neuroprotective agents such as norepinephrine and dopamine to optimize spinal cord perfusion pressure. Additionally, research into oxygen-carrying resuscitation fluids, such as hemoglobin-based oxygen carriers and perfluorocarbons, shows potential in improving oxygen delivery to the spinal cord during critical periods.

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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

Must not have

Ruptured aneurysm

Urgent or emergent aneurysm repairs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year

Awards & highlights

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a ruptured aneurysm.

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

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I cannot have a CSF drain due to a bleeding disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Spinal Cord Ischemia (SCI) involves the use of prophylactic cerebrospinal fluid (CSF) drains. This method works by reducing the pressure within the spinal cord, thereby improving spinal cord perfusion and preventing ischemia. By maintaining lower CSF pressure, the treatment helps ensure adequate blood flow to the spinal cord, which is essential for preventing damage due to insufficient oxygen and nutrient supply. This approach is particularly important for patients undergoing procedures like endovascular thoracoabdominal aneurysm repair, where the risk of SCI is elevated. Other treatments may include managing perioperative hypotension and ensuring adequate perfusion pressure, but CSF drainage remains a key preventive strategy.

Lumbar Cerebrospinal Fluid Drainage in Endovascular Aortic Repair - Reference Centre Experience.Naloxone infusion combined with cerebrospinal fluid monitoring and drainage during thoracic aorta exploration: a case report.The influence of regional spinal cord hypothermia on transcranial myogenic motor-evoked potential monitoring and the efficacy of spinal cord ischemia detection.