HES Patch Versus Blood Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02570724
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : August 28, 2018
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Intracranial Hypotension Drug: injection of HES " Voluven® " Biological: blood patch Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Biological: blood patch
Other Name: injection of autologous blood

Active Comparator: 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
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.

Primary Outcome Measures :
  1. 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%.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02570724

Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière
Strasbourg, Strasbourg Cedex, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02570724     History of Changes
Other Study ID Numbers: 5204
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
Intracranial Hypotension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes