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

N/ANot Yet RecruitingNCT07283536

Beijing Tiantan Hospital58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spontaneous Intracranial Hypotension

Interventions

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.

Blind epidural PRP patchPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain NRS of orthostatic headache

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

Time frame: 48 hours following epidural patch with PRP

Secondary Outcomes

Pain NRS of orthostatic headache

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 6 months following the first epidural patch with PRP

The occurrence of complications

Time frame: 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

Time frame: During the 6- month follow up