HES Patch Versus Blood Patch
关键词
抽象
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 09/28/2015 |
| 提交的预估入学人数: | 10/05/2015 |
| 首次发布: | 10/06/2015 |
| 上次提交的更新: | 08/18/2019 |
| 最近更新发布: | 08/19/2019 |
| 实际学习开始日期: | 05/31/2013 |
| 预计主要完成日期: | 07/31/2018 |
| 预计完成日期: | 07/31/2018 |
状况或疾病
干预/治疗
Drug: Drug: injection of HES " Voluven® " patch arm
Biological: Blood Patch arm
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 arm |
| 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: Drug: injection of HES " Voluven® " patch arm Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler [36 hours]
