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NCT Number: NCT07602556

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

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.

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Key information

Conditions

Spontaneous Intracranial Hypotension Brain Diseases Central Nervous System Diseases Intracranial Hypotension Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP Patch group

Procedure

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.

Whole Blood Patch Group

Procedure

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 outcomes

  1. The complete relief rate of patients with SIH

    Time frame: 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.

Secondary outcomes

  1. Pain intensity of orthostatic headache

    Time frame: 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).

  2. The complete relief rate of patients with SIH

    Time frame: 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.

  3. The good response rate of patients with SIH.

    Time frame: 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.

  4. The failure rate in each group.

    Time frame: 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.

  5. The recurrence rate in each group.

    Time frame: 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.

  6. Patients'quality of life

    Time frame: 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).

  7. Patients' overall satisfaction

    Time frame: 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.

  8. The occurrence of complications in each group.

    Time frame: During and after first epidural patch until the end of 6-month follow up.

  9. The percent of patients requiring repeat epidural patch in each group

    Time frame: Within 6- month follow up

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 22, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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