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

Two-site Blind Epidural Patch Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension: A Prospective, Assessor Blind, Randomized, Controlled, Noninferiority Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: Targeted epidural PRP patch; Procedure: Blind epidural PRP patch

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks.
2. Prior treatment with EBP at any time previously.

3. 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.

4. Unable to comprehend the pain NRS.
5. Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blind epidural PRP patch (BEPP); 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; 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.
Active Comparator: Targeted epidural PRP patch (TEPP); Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method.	Procedure: Targeted epidural PRP patch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain NRS of orthostatic headache	Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for orthostatic headache .	1, 3 and 6 months following epidural patch with PRP
The complete relief rate of epidural patch with PRP	The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.	48 hours, 1, 3 and 6 months after the initial targeted or blind patch
The good response rate of epidural patch with PRP	Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally.	48 hours, 1, 3 and 6 months post-procedurally
The failure rate of epidural patch with PRP	Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 48 hours following the initial epidural patch with PRP	48 hours following the initial epidural patch with PRP
The recurrence rate in each group.	Recurrence was defined as fresh onset of headaches beyond the 72-hour mark.	During the 6-month follow up
Patients' overall satisfaction	Patients' overall satisfaction was graded into very unsatisfactory (1), unsatisfactory (2), neutral (3), satisfactory (4) and very satisfactory (5), according to the Likert scale.	6 months following the first epidural patch with PRP
The occurrence of complications		During and after the epidural patch with PRP until the end of 6-month follow up
The percent of patients requiring repeat epidural PRP patch		During the 6- month follow up

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypotension
• Other Study ID Numbers: KY2023-263-03-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No