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HES Patch Versus Blood Patch

Primary Purpose

Intracranial Hypotension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
injection of HES " Voluven® "
blood patch
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Hypotension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Blood Patch arm

Drug: injection of HES " Voluven® " patch arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2015
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02570724
Brief Title
HES Patch Versus Blood Patch
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Patch arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Drug: injection of HES " Voluven® " patch arm
Arm Type
Active Comparator
Arm Description
Drug: injection of HES " Voluven® " into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds
Intervention Type
Drug
Intervention Name(s)
injection of HES " Voluven® "
Other Intervention Name(s)
HYDROXYETHYL STARCH
Intervention Description
Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.
Intervention Type
Biological
Intervention Name(s)
blood patch
Other Intervention Name(s)
injection of autologous blood
Primary Outcome Measure Information:
Title
Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler
Description
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%.
Time Frame
36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière
City
Strasbourg
State/Province
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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HES Patch Versus Blood Patch

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