HES Patch Versus Blood Patch

Not Applicable

Completed

• Conditions: Intracranial Hypotension
• Interventions: Biological: blood patch; Drug: injection of HES " Voluven® "

• Registration Number: NCT02570724
• Lead Sponsor: University Hospital, Strasbourg, France

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 Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects older than 18 years.·
• Subjects with an intracranial hypertension syndrome secondary to an epidural, spinal or lumbar puncture (and therefore presumed iatrogenic) with a sub arachnoid space or subjects with intracranial hypertension syndrome of primitive origin requiring treatment with epidural Patch ·
• subjects with a temporal window of sufficient quality to carry out the transcranial Doppler ·
• Subjects haven read the informed consent, signed and dated prior to the start of any proceedings related to the tial·
• Subjects affiliated to health insurance·
• Subjects having been informed of the results of a prior medical consultation

Exclusion Criteria

• Subjects with a cons-indication to an epidural Patch:
• blood disorders constitutional or acquired coagulation with platelets
• Subjects under treatment with curative doses of antiplatelet drugs or anticoagulants
• subjects under shock and / or hypovolemia
• subjects under generalized sepsis or at the puncture site
• any other cons-indication to performing an epidural

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Patch arm	blood patch	Standard of care arm: injection of autologous blood approximately 40 mL of blood sample into the epidural space at a rate of 1 ml / about 5 seconds.
Drug: injection of HES " Voluven® " patch arm	injection of HES " Voluven® "	Drug: injection of HES " Voluven® " into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds

Primary Outcome Measures

Name	Time	Method
Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler	36 hours	Compare the effect of epidural injection of autologous blood (Blood Patch) versus injection of a colloid (HES Voluven ®) on cerebral blood flow.; this study aims at observing the variation of the pulsatility index (PI) of middle cerebral artery observed by a transcranial Doppler between T0 and 30 minutes after the patch is administered.; The BP or HEA treatment will be considered equivalent if the proportion of clinical failures and side effects do not differ by more than 5%.

Trial Locations

Locations (1)

Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière; 🇫🇷 Strasbourg, Strasbourg Cedex, France