Spontaneous Intracranial HypotensionNCT07283536
Blind Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension
A study testing Targeted epidural PRP patch and Blind epidural PRP patch in people with Spontaneous Intracranial Hypotension, run by Beijing Tiantan Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Intracranial Hypotension
- What is being tested?
- Targeted epidural PRP patch and Blind epidural PRP patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent to participate the research obtained from the patient.
- Age 18-65 years.
- Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure.
- Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks.
Who cannot join
- 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 comprehend the pain NRS.
- Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.
About this study
Official title: Two-site Blind Epidural Patch Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension: A Prospective, Assessor Blind, Randomized, Controlled, Noninferiority Trial
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.
- Conditions
- Spontaneous Intracranial Hypotension
- Being tested
- Targeted epidural PRP patch, Blind epidural PRP patch
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted epidural PRP patchProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Blind epidural PRP patch (BEPP) | Experimental | Two-site blind epidural patch with PRP, which was prepared with the 2-stage centrifugation method, at levels C7-T1 and L4-5. Receives: Procedure: Blind epidural PRP patch |
| Targeted epidural PRP patch (TEPP) | Active comparator | Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method. Receives: Procedure: Targeted epidural PRP patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain NRS of orthostatic headache
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache.
Measured: 48 hours following epidural patch with PRP
Secondary outcomes (8)
Pain NRS of orthostatic headache
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for orthostatic headache .
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months following the first epidural patch with PRP
The occurrence of complications
Measured: 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
Measured: During the 6- month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Current literatures reported that MRM or non-dynamic CTM can not allow for adequate leak localization, so as not to guide targeted epidural patch. Leak detection requires dynamic CTM or DSA, which was not available for all our patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracranial HypotensionStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283536
- Sponsor's protocol ID
- KY2023-263-03-08
- Status last verified
- May 2026
- First submitted
- 4 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-site Blind Epidural Patch Versus Targeted Epidural Patch With Autologous Platelet-rich Plasma for Spontaneous Intracranial Hypotension: A Prospective, Assessor Blind, Randomized, Controlled, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07283536
- Acronym / sponsor ID
- KY2023-263-03-08
- Conditions
- Spontaneous Intracranial Hypotension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Current literatures reported that MRM or non-dynamic CTM can not allow for adequate leak localization, so as not to guide targeted epidural patch. Leak detection requires dynamic CTM or DSA, which was not available for all our patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind epidural PRP patch (BEPP) | Experimental | Procedure: Blind epidural PRP patchTwo-site blind epidural patch with PRP, which was prepared with the 2-stage centrifugation method, at levels C7-T1 and L4-5. |
| Targeted epidural PRP patch (TEPP) | Active comparator | Procedure: Targeted epidural PRP patchTargeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent to participate the research obtained from the patient.
- Age 18-65 years.
- Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure.
- Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks.
Key exclusion criteria (6 listed)
- 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 comprehend the pain NRS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted epidural PRP patchEach 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. | Procedure or surgery | Targeted epidural PRP patch (TEPP) |
| Blind epidural PRP patchPRP 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. | Procedure or surgery | Blind epidural PRP patch (BEPP) |
Primary outcome
Pain NRS of orthostatic headache
Time frame: 48 hours following epidural patch with PRP
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache.
8 secondary outcomes
Pain NRS of orthostatic headache
Time frame: 1, 3 and 6 months following epidural patch with PRP
The complete relief rate of epidural patch with PRP
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
Time frame: 48 hours, 1, 3 and 6 months post-procedurally
The failure rate of epidural patch with PRP
Time frame: 48 hours following the initial epidural patch with PRP
The recurrence rate in each group.
Time frame: During the 6-month follow up
Patients' overall satisfaction
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted epidural PRP patch and Blind epidural PRP patch in people with Spontaneous Intracranial Hypotension, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain NRS of orthostatic headache (time frame: 48 hours following epidural patch with PRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.