Intracranial HypotensionNCT02570724
HES Patch Versus Blood Patch
A study testing injection of HES " Voluven® " and blood patch in people with Intracranial Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracranial Hypotension
- What is being tested?
- injection of HES " Voluven® " and blood patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière
Strasbourg, Strasbourg Cedex, 67098
About this study
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
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
- Being tested
- injection of HES " Voluven® ", blood patch
- Medical subject headings
- Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of HES " Voluven® "Drug
Also called HYDROXYETHYL STARCH
Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.
blood patchBiological
Also called injection of autologous blood
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: injection of HES " Voluven® " |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570724
- Sponsor's protocol ID
- 5204
- Status last verified
- Aug 2019
- First submitted
- 29 Sep 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02570724
- Acronym / sponsor ID
- 5204
- Conditions
- Intracranial Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Patch arm | Active comparator | Biological: blood patchStandard 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® " patch arm | Active comparator | Drug: injection of HES " Voluven® "Drug: injection of HES " Voluven® " into the epidural space of 15 to 30 ml at a rate of 1 ml / about 5 seconds |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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·
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of HES " Voluven® "Also: HYDROXYETHYL STARCHInjection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds. | Drug | Drug: injection of HES " Voluven® " patch arm |
| blood patchAlso: injection of autologous blood | Biological | Blood Patch arm |
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of HES " Voluven® " and blood patch in people with Intracranial Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.