Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial

NCT07602556 | Not Yet Recruiting

• 1 other identifier: ky2023-263-03-09
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to leaks of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a new and promising alternative for current standard whole blood patching. However, there is no study comparing the efficacy and safety of the two approaches. In this study, we aimed to provide data concerning the outcomes of PRP patching versus conventional whole blood patching for treatment of refractory SIH cases failing in conservative therapy.

Conditions

Spontaneous Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

• The complete relief rate of patients with SIH

  The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.

  At 3 months after first epidural patch

Secondary Outcomes (9)

• Pain intensity of orthostatic headache

  At 48 hours, 2 weeks, 3 and 6 months after first epidural patch

• The complete relief rate of patients with SIH

  At 48 hours, 2 weeks and 6 months after first epidural patch

• The good response rate of patients with SIH.

  At 48 hours, 2 weeks, 3 and 6 months after first epidural patch

• The failure rate in each group.

  At 6 months after first epidural patch

• The recurrence rate in each group.

  At 6 months after first epidural patch

Study Arms (2)

PRP Patch (PP)

EXPERIMENTAL

Procedure: PRP Patch group

Whole blood patch (WP)

ACTIVE COMPARATOR

Procedure: Whole Blood Patch Group

Interventions

PRP Patch group PROCEDURE

Autologous PRP was prepared with the 2-stage centrifugation method and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The PRP mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.

PRP Patch (PP)

Whole Blood Patch Group PROCEDURE

Autologous whole blood was prepared and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The whole blood mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.

Whole blood patch (WP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent to participate the research obtained from the patient
• Satisfies the criteria for SIH according to the International Classification of Headache Disorders.

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 cooperate with postoperative evaluation, 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

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: May 16, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05