HES Patch Versus Blood Patch

Intracranial Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570724
• Other study ID #: 5204
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension

Intervention

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

Biological:
• blood patch

Locations

Country	Name	City	State
France	Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière	Strasbourg	Strasbourg Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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