Clinical Effect and Cerebral Vasoconstriction Induced After Epidural Blood Patch Versus Epidural Hydroxyethyl Starch Patch in Patients With Headache Due to Intracranial Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: blood patch (Biological)
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
干预措施: injection of HES " Voluven® " (Drug)
结局指标
主要结局
Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler
时间窗: 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%.
次要结局
未报告次要终点