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
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hypotension||Drug: injection of HES " Voluven® " Biological: blood patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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%.
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
|Contact: Pierre DIEMUNSCH, MD, PHD||03 88 12 70 firstname.lastname@example.org|
|Contact: Antoine CHARTON, MD||03 88 12 70 email@example.com|
|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|