HES Patch Versus 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.

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Key information

Conditions

Intracranial Hypotension Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Strasbourg, Strasbourg Cedex, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: HYDROXYETHYL STARCH

blood patch

Biological

Other names: injection of autologous blood

Primary outcomes

Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler

Time frame: 36 hours

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%.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Oct 7, 2015
Registry last updated: Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed