Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension
2026년 5월 22일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
218
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The complete relief rate of patients with SIH
기간: At 3 months after first epidural patch
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The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.
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At 3 months after first epidural patch
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity of orthostatic headache
기간: 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).
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At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
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The complete relief rate of patients with SIH
기간: At 48 hours, 2 weeks and 6 months after first epidural patch
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The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.
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At 48 hours, 2 weeks and 6 months after first epidural patch
|
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The good response rate of patients with SIH.
기간: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
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Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally.
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At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
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The failure rate in each group.
기간: At 6 months after first epidural patch
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Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally.
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At 6 months after first epidural patch
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The recurrence rate in each group.
기간: At 6 months after first epidural patch
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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
기간: At 3 and 6 months after first epidural patch
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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
기간: At 6 months after first epidural patch
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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.
기간: 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
기간: Within 6- month follow up
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Within 6- month follow up
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2028년 12월 1일
연구 완료 (추정된)
2029년 3월 1일
연구 등록 날짜
최초 제출
2026년 5월 16일
QC 기준을 충족하는 최초 제출
2026년 5월 16일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 22일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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