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Набор скоро начнётся NCT07602556

Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension

Без фазы С лечением Spontaneous Intracranial Hypotension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PRP Patch group, Whole Blood Patch Group.
Кому может быть актуально
Состояния в реестре: Spontaneous Intracranial Hypotension. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension: A Multi-center, Prospective, Randomized Controlled Trial

Обзор

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.

Вмешательства

  • Процедура 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.
  • Процедура 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.

Первичные конечные точки

  • The complete relief rate of patients with SIH [Срок оценки: At 3 months after first epidural patch]
Вторичные конечные точки (9)
  • Pain intensity of orthostatic headache [Срок оценки: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch]
  • The complete relief rate of patients with SIH [Срок оценки: At 48 hours, 2 weeks and 6 months after first epidural patch]
  • The good response rate of patients with SIH. [Срок оценки: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch]
  • The failure rate in each group. [Срок оценки: At 6 months after first epidural patch]
  • The recurrence rate in each group. [Срок оценки: At 6 months after first epidural patch]
  • Patients'quality of life [Срок оценки: At 3 and 6 months after first epidural patch]
  • Patients' overall satisfaction [Срок оценки: At 6 months after first epidural patch]
  • The occurrence of complications in each group. [Срок оценки: 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 [Срок оценки: Within 6- month follow up]

Критерии участия

Критерии включения

  • Informed consent to participate the research obtained from the patient
  • Satisfies the criteria for SIH according to the International Classification of Headache Disorders.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07602556 · ky2023-263-03-09

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗