Clinical Effect and Cerebral Vasoconstriction Induced After Epidural Blood Patch Versus Epidural Hydroxyethyl Starch Patch in Patients With Headache Due to Intracranial Hypotension
| Registry | NCT02570724 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | University Hospital, Strasbourg, France (Other) |
| Conditions | Intracranial Hypotension |
| Interventions | injection of HES " Voluven® ", blood patch (Drug, biological) |
| Dates | start 2013-06-01, primary completion 2018-08-01, completion 2018-08-01, first posted 2015-10-07, last updated 2019-08-20 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Intracranial Hypotension All trials of injection of HES " Voluven® " All trials of blood patch
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Blood Patch arm | Active comparator | Biological: 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 | Active comparator | Drug: 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 |
Sex: All, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière | Strasbourg, Strasbourg Cedex | France |