A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment

NCT03276975 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00083991
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF leaks to that of a simulated procedure without patching material in patients with spontaneous intracranial hypotension.

Conditions

Cerebrospinal Fluid Leaks

Keywords

CT fluoroscopy; epidural patching; spontaneous intracranial hypotension

Outcome Measures

Primary Outcomes (1)

• Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline

  Absolute change in median HIT-6 score from pre-procedural baseline to 1 month post procedure for each group. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.

  Baseline, 1 month

Secondary Outcomes (6)

• Change in Median HIT-6 Score From Baseline

  Baseline, 2 weeks, 4 months

• Reduction in Median Migraine Disability Assessment (MIDAS) Score From Baseline

  Baseline, 2 weeks, 1 month, 4 months

• Change in Median NRS Score From Baseline

  Baseline, 2 weeks, 1 month, 4 months

• Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline

  Baseline, 2 weeks, 1 month, 4 months

• Change in Median WPAI (Work Productivity and Activity Impairment) Score From Baseline

  Baseline, 2 weeks, 1 month, 4 months

Study Arms (2)

Patching of CSF Leaks with Autologous Blood and Fibrin

ACTIVE COMPARATOR

CT fluoroscopy-guided blood and fibrin glue patching targeted to the site of CSF leak.

Drug: TISSEEL

Simulated Patching Procedure

PLACEBO COMPARATOR

Instead of injection of blood and fibrin glue patching material through the needles, an equivalent volume of preservative free sterile Elliots B solution will be injected.

Drug: TISSEEL

Interventions

TISSEEL DRUG

TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (\>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients

Patching of CSF Leaks with Autologous Blood and Fibrin; Simulated Patching Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients meeting International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH (Table 1) who have had a contrast-enhanced brain MRI and a myelogram confirming the presence of a CSF leak will be recruited from the Duke Radiology spine intervention clinic \[25\]

You may not qualify if:

• recent (i.e., \< 2 weeks) blood patch
• contraindication or inability to undergo the procedure
• inability to provide informed consent
• expected inability to complete follow-up assessment
• a contraindication to receiving contrast material (precluding an epidurogram)
• contraindication to receiving fibrin glue (i.e., allergy).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak; Intracranial Hypotension

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Timothy J. Amrhein, MD
• Organization: Duke University Medical Center

timothy.amrhein@duke.edu

9196841909

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 8, 2017
• Study Start: December 18, 2017
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Locations

US (1)