HES Patch Versus Blood Patch

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracranial Hypotension

Intervention / Treatment
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* Drug: injection of HES  Voluven® 
* Biological: blood patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blood Patch arm<br>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. | Biological: blood patch<br> <br> * Other names: injection of autologous blood;|
| Active Comparator: Drug: injection of HES  Voluven®  patch arm<br>Drug: injection of HES  Voluven®  into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds | Drug: injection of HES  Voluven® <br>* Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.<br>* Other names: HYDROXYETHYL STARCH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler | 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%. | 36 hours |