HES Patch Versus Blood Patch

NCT ID: NCT02570724

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-08-31

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.

Conditions

Intracranial Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blood Patch arm

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.

Group Type: ACTIVE_COMPARATOR

blood patch

Intervention Type: BIOLOGICAL

Drug: injection of HES " Voluven® " patch arm

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

Group Type: ACTIVE_COMPARATOR

injection of HES " Voluven® "

Intervention Type: DRUG

Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.

Interventions

injection of HES " Voluven® "

Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.

Intervention Type: DRUG

blood patch

Intervention Type: BIOLOGICAL

Other Intervention Names

HYDROXYETHYL STARCH; injection of autologous blood

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière

Strasbourg, Strasbourg Cedex, France

Countries

France

Other Identifiers

5204

Identifier Type: -

Identifier Source: org_study_id