Spontaneous Intracranial HypotensionNCT07602556
Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension
A study testing PRP Patch group and Whole Blood Patch Group 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 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Intracranial Hypotension
- What is being tested?
- PRP Patch group and Whole Blood Patch Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent to participate the research obtained from the patient
- Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
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 cooperate with postoperative evaluation, treatment, rehabilitation, and follow-up visits
About this study
Official title: 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.
- Conditions
- Spontaneous Intracranial Hypotension
- Being tested
- PRP Patch group, Whole Blood Patch Group
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP Patch groupProcedure or surgery
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.
Whole Blood Patch GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP Patch (PP) | Experimental | Not described Receives: Procedure: PRP Patch group |
| Whole blood patch (WP) | Active comparator | Not described Receives: Procedure: Whole Blood Patch Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months after first epidural patch
Secondary outcomes (9)
Pain intensity of orthostatic headache
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At 6 months after first epidural patch
The occurrence of complications in each group.
Measured: 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
Measured: Within 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 posted22 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
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
- 218 participants (estimated)
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
- NCT07602556
- Sponsor's protocol ID
- ky2023-263-03-09
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07602556
- Acronym / sponsor ID
- ky2023-263-03-09
- Conditions
- Spontaneous Intracranial Hypotension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 May 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Patch (PP) | Experimental | Procedure: PRP Patch group |
| Whole blood patch (WP) | Active comparator | Procedure: Whole Blood Patch Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent to participate the research obtained from the patient
- Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
Key exclusion criteria (5 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 cooperate with postoperative evaluation, treatment, rehabilitation, and follow-up visits
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 |
|---|---|---|
| PRP Patch groupAutologous 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. | Procedure or surgery | PRP Patch (PP) |
| Whole Blood Patch GroupAutologous 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. | Procedure or surgery | Whole blood patch (WP) |
Primary outcome
The complete relief rate of patients with SIH
Time frame: At 3 months after first epidural patch
The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.
9 secondary outcomes
Pain intensity of orthostatic headache
Time frame: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
The complete relief rate of patients with SIH
Time frame: At 48 hours, 2 weeks and 6 months after first epidural patch
The good response rate of patients with SIH.
Time frame: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
The failure rate in each group.
Time frame: At 6 months after first epidural patch
The recurrence rate in each group.
Time frame: At 6 months after first epidural patch
Patients'quality of life
Time frame: At 3 and 6 months after first epidural patch
Patients' overall satisfaction
Time frame: At 6 months after first epidural patch
The occurrence of complications in each group.
Time frame: 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
Time frame: Within 6- month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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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.
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 PRP Patch group and Whole Blood Patch Group 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 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?
This study is still under way. Results are not available in the source record yet.
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?
The complete relief rate of patients with SIH (time frame: At 3 months after first epidural patch). 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 27 May 2026.