HES Patch Versus Blood Patch

University Hospital, Strasbourg, France

Status: Completed

Conditions: Intracranial Hypotension

Treatments: Drug: injection of HES " Voluven® "; Biological: blood patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02570724

5204

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Blood Patch arm

Active Comparator group

Description:

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.

Treatment:

Biological: blood patch

Drug: injection of HES " Voluven® " patch arm

Active Comparator group

Description:

Drug: injection of HES " Voluven® " into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds

Treatment:

Drug: injection of HES " Voluven® "