Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension

NCT07283536 | Not Yet Recruiting

• 1 other identifier: KY2023-263-03-08
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to loss of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a successful alternative for whole blood in dura repair. However, there is no report regarding the best approach to use: targeted epidural PRP patch (TEPP) versus blind epidural PRP patch (BEPP). Preliminary work has suggested that both targeted and blind approaches are effective when using whole blood for epidural patch. Furthermore, two-site blind approach could be considered as a viable initial treatment regardless of the identification of the leak for conventional targeted approach. In this study, the investigators aimed to investigate the non-inferiority of two-site BEPP compared with TEPP for the treatment of refractory SIH cases failing in conservative therapy.

Conditions

Spontaneous Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

• Pain NRS of orthostatic headache

  Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache.

  48 hours following epidural patch with PRP

Secondary Outcomes (8)

• Pain NRS of orthostatic headache

  1, 3 and 6 months following epidural patch with PRP

• The complete relief rate of epidural patch with PRP

  48 hours, 1, 3 and 6 months after the initial targeted or blind patch

• The good response rate of epidural patch with PRP

  48 hours, 1, 3 and 6 months post-procedurally

• The failure rate of epidural patch with PRP

  48 hours following the initial epidural patch with PRP

• The recurrence rate in each group.

  During the 6-month follow up

Study Arms (2)

Blind epidural PRP patch (BEPP)

EXPERIMENTAL

Two-site blind epidural patch with PRP, which was prepared with the 2-stage centrifugation method, at levels C7-T1 and L4-5.

Procedure: Blind epidural PRP patch

Targeted epidural PRP patch (TEPP)

ACTIVE COMPARATOR

Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method.

Procedure: Targeted epidural PRP patch

Interventions

Targeted epidural PRP patch PROCEDURE

Each patient was subjected to either magnetic resonance myelography (MRM) or/and computed tomography myelography (CTM) to detect the location of CSF leaking. PRP was prepared with the 2-stage centrifugation method and a standard epidural puncture was conducted at the definitive CSF leak locations under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.

Targeted epidural PRP patch (TEPP)

Blind epidural PRP patch PROCEDURE

PRP was prepared with the 2-stage centrifugation method and the investigators chose two separate sites for epidural access, the C7-T1 and L4-5 levels. A standard epidural puncture was conducted under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.

Blind epidural PRP patch (BEPP)

Eligibility Criteria

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

You may qualify if:

• Informed consent to participate the research obtained from the patient.
• Age 18-65 years.
• Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure.
• Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks.

You may not qualify if:

• There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks.
• Prior treatment with EBP at any time previously.
• Any contraindication to epidural puncture, such as space-occupying intracranial or intraspinal lesions, spinal defect, suspected infection over the puncture site, bleeding disorder and current anticoagulation therapy.
• History of drug and alcohol abuse, cognitive dysfunction, or mental illness.
• Unable to comprehend the pain NRS.
• Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Intracranial Hypotension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Fang Luo, Professor

CONTACT

+86 010 59976664; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12