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HES Patch Versus Blood Patch

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ClinicalTrials.gov Identifier: NCT02570724
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Intracranial Hypotension Drug: injection of HES " Voluven® " Biological: blood patch

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : June 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
Other Name: HYDROXYETHYL STARCH


Outcome Measures

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%.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02570724


Contacts
Contact: Pierre DIEMUNSCH, MD, PHD 03 88 12 70 76 pierre-diemunsch@chru-strasbourg.fr
Contact: Antoine CHARTON, MD 03 88 12 70 76 antoine.charton@chru-strasbourg.fr

Locations
France
Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière Recruiting
Strasbourg, Strasbourg cedex, France, 67098
Contact: Antoine Charton, MD    03 88 12 70 75      
Sub-Investigator: CHARTON ANTOINE, MD         
Principal Investigator: PIERRE DIEMUNSCH, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02570724     History of Changes
Other Study ID Numbers: 5204
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

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