Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension
22. mai 2026 oppdatert av: Fang Luo, Beijing Tiantan Hospital
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
218
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Informed consent to participate the research obtained from the patient
- Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
Exclusion Criteria:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: PRP Patch (PP)
|
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.
|
|
Aktiv komparator: Whole blood patch (WP)
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The complete relief rate of patients with SIH
Tidsramme: 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.
|
At 3 months after first epidural patch
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity of orthostatic headache
Tidsramme: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
|
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain).
|
At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
|
|
The complete relief rate of patients with SIH
Tidsramme: At 48 hours, 2 weeks and 6 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.
|
At 48 hours, 2 weeks and 6 months after first epidural patch
|
|
The good response rate of patients with SIH.
Tidsramme: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
|
Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally.
|
At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
|
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The failure rate in each group.
Tidsramme: At 6 months after first epidural patch
|
Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally.
|
At 6 months after first epidural patch
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The recurrence rate in each group.
Tidsramme: At 6 months after first epidural patch
|
Recurrence was defined as fresh onset of orthostatic headache in completely relieved patients beyond the 72-hour mark.
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At 6 months after first epidural patch
|
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Patients'quality of life
Tidsramme: At 3 and 6 months after first epidural patch
|
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).
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At 3 and 6 months after first epidural patch
|
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Patients' overall satisfaction
Tidsramme: At 6 months after first epidural patch
|
Patients' overall satisfaction was graded into very unsatisfactory (1), unsatisfactory (2), neutral (3), satisfactory (4) and very satisfactory (5), according to the Likert scale.
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At 6 months after first epidural patch
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The occurrence of complications in each group.
Tidsramme: During and after first epidural patch until the end of 6-month follow up.
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During and after first epidural patch until the end of 6-month follow up.
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The percent of patients requiring repeat epidural patch in each group
Tidsramme: Within 6- month follow up
|
Within 6- month follow up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. mars 2029
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
16. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ky2023-263-03-09
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