Injection of plasma-rich fibrin for treating postdural puncture headaches
Plasma Rich Fibrin Epidural Injection by Racz Catheter in Postdural Puncture Headache Guided Optic Nerve Sheath Diameter
This study is testing whether injections of plasma-rich fibrin can help people with postdural puncture headaches feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06790758 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of plasma-rich fibrin (PRF) epidural injections administered via a Racz catheter for patients suffering from postdural puncture headaches (PDPHs). The approach involves using PRF, which is derived from the patient's own blood and contains growth factors that may promote healing. The optic nerve sheath diameter (ONSD) will be monitored to assess changes in intracranial pressure, which can be related to the severity of PDPHs. The study aims to provide a novel treatment option for this common complication following dural puncture procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who are experiencing severe postdural puncture headaches.
Not a fit: Patients with severe comorbid conditions, those on anticoagulant therapy, or individuals with a BMI of 35 kg/m2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate the pain and complications associated with postdural puncture headaches.
How similar studies have performed: While the use of plasma-rich fibrin in pain management is gaining popularity, this specific application for postdural puncture headaches is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 65 years. * Both sexes. * Patients suffering from severe post-dural puncture headache. Exclusion Criteria: * Uncooperative patients. * Severe comorbid conditions. * Pregnancy. * Anticoagulant therapy. * Known allergies to plasma rich fibrin components. * Body mass index (BMI) ≥35 kg/m2.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.