Clinical Trial: HES Patch Versus Blood Patch

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Effect and Cerebral Vasoconstriction Induced After Epidural Blood Patch Versus Epidural Hydroxyethyl Starch Patch in Patients With Headache Due to Intracranial Hypotensi

Brief Summary: The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever, sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood patch. This alternative technique is simple to implement and does not have some of the specific blood pressure contra-indications. The study aims at comparing the "Blood Patch" group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the anesthetist, ease of implementation and effect of the injection of epidural anesthesia on cerebral blood flow within 24 hours.

Detailed Summary:
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler [ Time Frame: 36 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: September 29, 2015
Date Started: June 2013
Date Completion: June 2017
Last Updated: October 6, 2015
Last Verified: September 2015