HES Patch Versus Blood Patch

NCT02570724 | Completed DMC

• 1 other identifier: 5204
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Blood Patch arm

ACTIVE COMPARATOR

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

Drug: injection of HES " Voluven® " patch arm

ACTIVE COMPARATOR

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® "

Interventions

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.

Also known as: HYDROXYETHYL STARCH

Drug: injection of HES " Voluven® " patch arm

blood patch BIOLOGICAL

Also known as: injection of autologous blood

Blood Patch arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, Strasbourg Cedex, 67098, France

Location

MeSH Terms

Conditions

Intracranial Hypotension

Interventions

Hydroxyethyl Starch Derivatives; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 7, 2015
• Study Start: June 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

FR (1)