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临床试验/NCT01357057
NCT01357057已完成不适用

Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
530
试验地点
1
主要终点
Mortality and Full recovery (Rankin 0-1) at ICU discharge

研究概览

简要总结

The goal of this observational study is to develop and validate a predictive score of 1-year outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.

Using our database filled up prospectively, the investigators plan to collect clinical, biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score in a validation cohort (from 2008 to 2009).

详细描述

The investigators plan to screen all patients who were consecutively admitted from January 1, 2003 to our neurosurgical intensive care unit after a clinical diagnosis of SAH confirmed by cerebral angiography and treated with a coiling procedure. Patients for whom a decision was made by the treating physician to either forego any invasive treatment or to perform open surgical clipping were excluded. Clinical, biological and radiological characteristics will be recorded during the course of hospitalization. This observational study will be performed according to standard procedure.

Admission characteristics. At admission, the investigators plan to anonymously record age, sex, GCS, presence of motor deficit, presence of clinical seizure and WFNS score. The GCS refers to the value at admission before any treatment with sedative drugs. The cohort was divided into two groups, an admission coma group for patients with GCS<13 (WFNS 4 or 5), and a non-coma group for patients with GCS313 (WFNS 1 to 3).

Admission biological sampling of venous blood are routinely performed to measure S100beta and troponin per standard clinical practice in our ICU. Troponin I and S100beta levels will be considered high for values higher than 0.5 mg/L (corresponding to 5 times the maximum normal range) to be consistent with previous studies and to ensure high specificity.

Admission radiological characteristics are obtained from the admission CT-scan and the initial angiogram. The CT-scan will be reviewed by a neuro-radiologist and classified according to the modified Fisher score. Hydrocephalus and intraventricular hemorrhage at admission were also registered. Aneurysm site and number of aneurysms were obtained from the initial angiogram.

ICU Management. The ICU management will not be modified for this study. Briefly, a central venous line and an arterial catheter are routinely inserted at admission before coiling. An external ventricular drain (EVD) is inserted in patients with CT evidence of hydrocephalus, WFNS grade between III to V, or a transcranial Doppler pulsatility index greater than 1.2, suggestive of increased intracranial pressure. The EVD is routinely connected to an external pressure strain gauge to monitor ICP according to a recently published protocol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years old
  • Acute aneurysmal subarachnoid hemorrhage
  • Decision of coiling intervention
  • Admission and ICU management in our center.

排除标准

  • Other intervention than coiling (surgery of nor surgery, nor coiling intervention)

结局指标

主要结局

Mortality and Full recovery (Rankin 0-1) at ICU discharge

时间窗: at 1-year

次要结局

  • Early cerebral complication(Within the first week of ICU stay)
  • Delayed cerebral complication(for the duration of hospital stay, an expected average of 3 weeks with an expected maximum of 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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