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

Capital Medical University

Status: Not yet enrolling

Conditions: Spontaneous Intracranial Hypotension

Treatments: Procedure: Targeted epidural PRP patch; Procedure: Blind epidural PRP patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07283536

KY2023-263-03-08

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Blind epidural PRP patch (BEPP)

Experimental group

Description:

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

Treatment:

Procedure: Blind epidural PRP patch

Targeted epidural PRP patch (TEPP)

Active Comparator group

Description:

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

Treatment:

Procedure: Targeted epidural PRP patch