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Clinical multicenter study of ICP guided 3D print-assisted minimally invasive treatment of hypertensive supratentorial intracerebral hemorrhage
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注册号:

Registration number:

ChiCTR2200055647 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 ICP导向3D打印辅助下高血压性幕上脑出血微创治疗的临床多中心研究 

Public title:

Clinical multicenter study of ICP guided 3D print-assisted minimally invasive treatment of hypertensive supratentorial intracerebral hemorrhage 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ICP导向3D打印辅助下高血压性幕上脑出血微创治疗的临床多中心研究 

Scientific title:

Clinical multicenter study of ICP guided 3D print-assisted minimally invasive treatment of hypertensive supratentorial intracerebral hemorrhage 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

王炬 

研究负责人:

冯光 

Applicant:

Wangju 

Study leader:

Fengguang 

申请注册联系人电话:

Applicant telephone:

13733835674 

研究负责人电话:

Study leader's telephone:

18903711799 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

13733835674@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fengguang@zzu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

河南省郑州市金水区纬五路7号 

研究负责人通讯地址:

河南省郑州市金水区纬五路7号 

Applicant address:

7 Weiwu Road, Jinshui District, Zhengzhou City, Henan Province, China 

Study leader's address:

7 Weiwu Road, Jinshui District, Zhengzhou City, Henan Province, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

河南省人民医院 

Applicant's institution:

Henan Provincial People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

河南省人民医院 神经外科ICU 

Primary sponsor:

ICU of Neurosurgery, Henan Provincial People's Hospital 

研究实施负责(组长)单位地址:

河南省郑州市金水区纬五路7号 

Primary sponsor's address:

7 Weiwu Road, Jinshui District, Zhengzhou City, Henan Province, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

高血压性幕上脑出血 

Target disease:

Hypertensive supratentorial intracerebral hemorrhage 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

探讨ICP导向3D打印微创治疗技术在高血压脑出血临床应用价值,分析影响3D打印微创治疗高血压脑出血患者预后的相关因素 

Objectives of Study:

To explore the clinical application value of ICP guided 3D printing in minimally invasive treatment of hypertensive intracerebral hemorrhage, and to analyze the factors affecting the prognosis of patients with hypertensive intracerebral hemorrhage treated by 3D printing 

药物成份或治疗方案详述:

签署知情同意书后,符合纳入标准,根据家属治疗意愿应用3D打印辅助微创治疗或是常规开颅手术治疗,将患者进一步分为试验组(3D打印辅助微创治疗治疗组)和对照组(开颅治疗组)。 对照组(开颅组):选择扩大翼点骨瓣开颅显微镜下经侧裂血肿清除术, 根据术中血肿清除后脑组织搏动及肿胀程度,决定是否需去骨瓣减压术。手术方式:扩大翼点开颅,悬吊硬膜一周,弧形“X”形剪开硬脑膜,分开侧裂进入血肿腔,由血肿内部逐渐清除血肿,当清除大部分血肿后可显露出血责任动脉,妥善电凝,避免损伤血肿腔周围脑组织。 试验组(ICP导向3D打印辅助微创治疗治疗组):行 3D 打印导板定位下颅内血肿穿刺引流术治疗。术前行床旁头颅 CT 薄层扫描,获取 DICAM 格式图像数据,将 数据导入 Mimics 软件, 建立头颅三维模型及血肿模型, 构建术区面部膜片,进行波尔运算,设计穿刺路径,模型完成后,打印手术导板,环氧乙烷进行消毒。 取平卧位,剃除头发,麻醉成功后,常规消毒、铺巾。先将颅内压监测探头(Codman)植入同侧侧脑室,实时监测ICP数值。然后将3D导板戴在患者面部,紧贴面部、鼻梁等,确保鼻根、患侧外耳道定位准确, 用龙胆紫做穿刺点标记。去除导板,在穿刺点作 5 mm 左右长切口,切开头皮,戴好面部导板,紧贴皮肤,沿穿刺通道钻骨孔 1 个,穿透硬脑膜,用带导针引流管沿穿刺通道进入血肿腔内,深度为已测量引流管长度。 流出暗红色液体后, 拔出导丝。抽出少许暗红色液体,引流通畅后固定引流管,缝合头皮,接引流袋。 术后根据颅内压监测情况给予甘露醇脱水降颅压,ICP维持在20mmHg以下,保持脑灌注压在65~85mmHg;术后引流管最高点置于双侧外耳道上约10 cm并保持持续引流,术后约24 h血肿腔内注入尿激酶,3万U溶于5 ml生理盐水,每日1次,夹闭引流管 3 h 后开放引流,持续3d。术后一般3d复查颅脑CT,如有病情变化, 随时复查CT,一般7 d内根据血肿引流情况拔除引流管。 术后上述两组患者均给与降低颅内压、防治脑水肿、控制血压、营养脑细胞、纠正电解质紊乱及酸碱失衡、防治缺氧及CO2蓄积等治疗措施 

Description for medicine or protocol of treatment in detail:

After signing the informed consent, the patients met the inclusion criteria and were further divided into the experimental group (3D print-assisted minimally invasive treatment group) and the control group (craniotomy treatment group) according to the treatment wishes of their family members. Control group (craniotomy group) : the enlarged pterional bone flap craniotomy was performed to remove the hematomas through the lateral fissure under the microscope. According to the pulsing and swelling degree of the brain tissue after the removal of the hematomas during the operation, the decompression of the bone flap was determined. Surgical method: craniotomy with enlarged pteria, hanging the dura for a week, cutting the dura in the shape of arc "X", and entering the hematoma cavity by separating the lateral split, gradually removing the hematoma from inside the hematoma. After removing most of the hematoma, the responsible artery of bleeding can be exposed, and proper electrocoagulation can avoid damaging the brain tissue around the hematoma cavity. Experimental group (ICP guided 3D print-assisted minimally invasive treatment group) : Intracranial hematoma was treated by puncture and drainage with 3D printed guide plate positioning. Preoperative bedside CT thin layer scan was performed to obtain DICAM format image data Data were imported into THE Mimics software to establish a THREE-DIMENSIONAL model of the head and hematoma model, construct the facial diaphragm in the surgical area, conduct Bohr calculation, and design the puncture path. After the model was completed, the surgical guide was printed and epoxy ethane was used for disinfection. Take the supine position, shave the hair, after the success of anesthesia, routine disinfection, towel. Intracranial pressure monitoring probe (Codman) was implanted into ipsilateral lateral ventricle to monitor ICP value in real time. Then, the 3D guide plate was worn on the patient's face, close to the face and bridge of the nose, etc., to ensure accurate positioning of the nasal root and external auditory canal on the affected side, and gentian violet was used to mark the puncture point. Remove the guide plate at the puncture point The scalp was cut with a length of about 5 mm, and the facial guide plate was worn, which was close to the skin. A bone hole was drilled along the puncture channel to penetrate the dura mater, and the drainage tube with guide needle was used to enter the hematoma cavity along the puncture channel. The depth of the drainage tube was measured. After discharging dark red liquid, pull out guide wire. Extract a little dark red liquid, fix the drainage tube after smooth drainage, suture the scalp, and connect the drainage bag. After surgery, according to the monitoring of intracranial pressure, mannitol dehydration was given to reduce intracranial pressure. ICP was maintained below 20mmHg and cerebral perfusion pressure was maintained between 65 and 85mmHg. The highest point of the drainage tube was placed about 10 cm above bilateral external auditory meatus and sustained drainage was maintained. Urokinase was injected into the hematoma cavity about 24 h after surgery, and 30,000 U was dissolved in 5 mL normal saline, once a day. The drainage tube was clamped for 3 h and then opened for drainage, lasting for 3 days. Brain CT is generally reviewed 3d after surgery. If the condition changes, CT can be reviewed at any time, and the drainage tube can be removed within 7 days according to the hematoma drainage. After surgery, the two groups of patients 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

①年龄>18岁者; ②发病24 h内入院者; ③符合全国第4届脑血管病学术会议制订的HICH临床诊断标准,并经头颅CT检查确诊者; ④幕上出血量20~40 mL (取发病24 h内头颅CT图像估算血肿体积,公式为 V=A×B×C/2,其中A是最大出血层面上的最大直径,B是垂直于此的最大直径,C是垂直血肿深度); ⑥患者及其家属知情同意。 

Inclusion criteria

169/5000 ① Age >18 years old; ② Patients admitted to hospital within 24 hours after onset; ③ Those who met the HICH clinical diagnostic criteria formulated by the 4th National Academic Conference on Cerebrovascular Diseases and were confirmed by head CT examination; ④ The amount of supratentorial blood loss was 20-40 mL (The hematoma volume was estimated by head CT image within 24 h of onset, and the formula was V=A×B×C/2, where A was the maximum diameter at the level of maximum bleeding, B was the maximum diameter perpendicular to this, and C was the depth of vertical hematoma); ⑥ Informed consent of patients and their families. 

排除标准:

①创伤性脑出血者; ②术前脑疝 ③脑动脉瘤破裂、脑静脉畸形、颅内肿瘤、血管淀粉样变性、血管炎、外伤性因素、脑梗死及溶栓术后等其他明确病因所致出血者; ⑤入院前已在外院行外科手术者; ⑥合并多脏器功能衰竭者; ⑦全身性感染性疾病者; ⑧合并恶性肿瘤、血液系统疾病、免疫系统疾病; ⑨合并精神疾病伴认知功能障碍的患者; ⑩基本资料不完整者及中途退出患者。 

Exclusion criteria:

① Traumatic cerebral hemorrhage; ② Preoperative cerebral hernia ③ Bleeding caused by rupture of cerebral aneurysm, cerebral venous malformation, intracranial tumor, amyloidosis, vasculitis, traumatic factors, cerebral infarction and after embolus and other clear causes; (5) patients who had undergone surgical operations in other hospitals before admission; ⑥ Patients with multiple organ failure; ⑦ Patients with systemic infectious diseases; ⑧ complicated with malignant tumor, blood system diseases, immune system diseases; ⑨ Patients with mental diseases and cognitive dysfunction; ⑩ Patients with incomplete basic information and those who have dropped out. 

研究实施时间:

Study execute time:

From2022-03-01To 2023-03-01 

征募观察对象时间:

Recruiting time:

From2022-03-01To 2023-01-01 

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究从伦理及患者安全性角度考虑,采用非随机方法根据患者家属意愿是否采用目标化体温管理进行分组。

Randomization Procedure (please state who generates the random number sequence and by what method):

From the perspective of ethics and patient safety, this study adopted a non-randomized method to divide patients into groups according to their family members' willingness to adopt targeted temperature management.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2025年12月

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

In December 2025

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

由数据收集人员根据CRF表进行收集,数据管理委员会对数据进行分析,并对数据的真实性进行管理控制。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The data collection personnel will collect the data according to the CRF table, and the data management committee will analyze the data and manage the authenticity of the data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-15
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