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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Patch arm | Active Comparator | 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 | Active Comparator | Drug: injection of HES " Voluven® " into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of HES " Voluven® " | Drug | Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière | Strasbourg | Strasbourg Cedex | 67098 | France |
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| ID | Term |
|---|---|
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D017217 | Blood Patch, Epidural |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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|
| blood patch | Biological |
|
|
| D011134 |
| Polysaccharides |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |