Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRP Patch group, Whole Blood Patch Group.
- Who it may be relevant to
- Registry conditions: Spontaneous Intracranial Hypotension. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial
Overview
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.
Interventions
- Procedure PRP Patch group
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. - Procedure Whole Blood Patch Group
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.
Primary outcome measures
- The complete relief rate of patients with SIH [Time frame: At 3 months after first epidural patch]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07602556 · ky2023-263-03-09