Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: PRP Patch group; Procedure: Whole Blood Patch Group

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

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: PRP Patch (PP)	Procedure: PRP Patch group; 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.
Active Comparator: Whole blood patch (WP)	Procedure: Whole Blood Patch Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity of orthostatic headache	Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain).	At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
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 48 hours, 2 weeks and 6 months after first epidural patch
The good response rate of patients with SIH.	Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally.	At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
The failure rate in each group.	Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally.	At 6 months after first epidural patch
The recurrence rate in each group.	Recurrence was defined as fresh onset of orthostatic headache in completely relieved patients beyond the 72-hour mark.	At 6 months after first epidural patch
Patients'quality of life	Patients'quality of life was evaluated by Headache Impact Test (HIT-6), with six item scores of headache-related disability divided into 36-49 (little or no impact), 50-55 (some impact), 56-59 (substantial impact), and ≥60 (severe impact).	At 3 and 6 months after first epidural patch
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.	At 6 months after first epidural patch
The occurrence of complications in each group.		During and after first epidural patch until the end of 6-month follow up.
The percent of patients requiring repeat epidural patch in each group		Within 6- month follow up

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 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: ky2023-263-03-09

Drug and device information, study documents

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