Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension
NCT ID: NCT07283536
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
58 participants
INTERVENTIONAL
2025-12-20
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Targeted epidural PRP patch (TEPP)
Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Professor
Central Contacts
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Other Identifiers
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KY2023-263-03-08
Identifier Type: -
Identifier Source: org_study_id