Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension
22 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
218
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The complete relief rate of patients with SIH
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain intensity of orthostatic headache
Délai: 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
Délai: 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.
Délai: 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
|
|
The failure rate in each group.
Délai: 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
|
|
The recurrence rate in each group.
Délai: 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.
|
At 6 months after first epidural patch
|
|
Patients'quality of life
Délai: 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).
|
At 3 and 6 months after first epidural patch
|
|
Patients' overall satisfaction
Délai: 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.
|
At 6 months after first epidural patch
|
|
The occurrence of complications in each group.
Délai: During and after first epidural patch until the end of 6-month follow up.
|
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
Délai: Within 6- month follow up
|
Within 6- month follow up
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 mai 2026
Achèvement primaire (Estimé)
1 décembre 2028
Achèvement de l'étude (Estimé)
1 mars 2029
Dates d'inscription aux études
Première soumission
16 mai 2026
Première soumission répondant aux critères de contrôle qualité
16 mai 2026
Première publication (Réel)
22 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ky2023-263-03-09
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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