登记号
CTR20130780
相关登记号
曾用名
药物类型
无
临床申请受理号
企业选择不公示
适应症
重症创伤性脑损伤
试验通俗题目
重症创伤性脑损伤患者中静脉用黄体酮的有效性和安全性
试验专业题目
关于黄体酮治疗重症创伤性脑损伤有效性和安全性的随机、双盲、安慰剂对照III期临床研究
试验方案编号
BHR-100-301
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
Neta R. Nelson
联系人座机
001-703-964-3033
联系人手机号
联系人Email
nnelson@bhr-pharma.com
联系人邮政地址
607 Herndon Parkway, Suite 110 Herndon, VA, USA
联系人邮编
20170
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
SyNAPSe试验将研究在受伤后8小时内给予静脉（i.v.）黄体酮治疗120小时是否能对重症创伤性脑损伤患者改善其恢复。
随机化
随机化
盲法
双盲
试验范围
NK
设计类型
平行分组
年龄
16/18岁(最小年龄)至
70岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 年龄在16岁-70岁（含16岁和70岁）的男女患者（或当地法规要求的最低年龄限）。
- 体重为45-135kg（含45和135kg）
- 研究治疗开始前遭受闭合性头部外伤不超过8小时
- 根据病史及临床检查诊断为TBI
- 复苏术后GCS评分在4-8分（包括）
- 至少有一侧瞳孔有反应
- 因与入院时CT扫描一致的异常情况而证实的TBI（弥漫性损伤II-VI, Marshall CT分级）
- 根据ICP监测指示
排除标准
- 研究者判断的预期存活时间不足24小时
- 根据研究者判断，不能或不愿意遵循方案直至完成末次访视的受试者（受伤后6个月）
- 入院后长时间持续和/或不能纠正的低氧（Pa02< 60 mmHg）或低血压（收缩压< 90 mmHg）
- 任何脊髓损伤
- 妊娠
- 穿通性头部外伤
- 随机化时双侧瞳孔散大固定
- 怀疑主要由其它原因引起的昏迷（如酒精）
- 单纯的硬膜外血肿
- 以前存在重大临床疾病或在入院时可确定的慢性疾病，并有可能影响功能预后
- 复苏术后严重的心脏或血流动力学不稳定
- 已知在受伤30天内接受过其它研究药物或手术治疗
- 对黄体酮及相关药物或输液成份有过敏反应史
- 根据研究者的判断，具有任何不稳定或可能危害研究过程中患者安全及其依从性的疾病
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:黄体酮脂肪乳
|
用法用量:在第1小时内静输注药的负荷剂量为0.71 mg/kg/hr，然后以 0.5 mg/kg/hr剂量进行119小时的连续维持输注。
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:不含黄体酮的脂肪乳
|
用法用量:在第1小时内安慰剂的负荷剂量为0.71 mg/kg/hr，然后以 0.5 mg/kg/hr剂量进行119小时的连续维持输注。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 格拉斯哥预后评分 | 受伤后6个月 | 企业选择不公示 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| GOS评价 | TBI后3个月时 | 企业选择不公示 |
| GOS-E评价 | TBI后3个月及6个月 | 企业选择不公示 |
| SF-36 | TBI后第3个月和6个月 | 企业选择不公示 |
| ICP、CPP及TIL变化 | 入院及第6天输液后 | 企业选择不公示 |
| CT扫描判断的颅内病理改变 | 入院及第6天输液后 | 企业选择不公示 |
| 死亡率 | TBI后1个月及6个月 | 企业选择不公示 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
无
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 |
|---|
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| Groupe Hospitalier Pellegrin | France | Aquitaine | Bordeaux | |
| H？pital Central – CHU de Nancy | France | Limousin, Lorraine | Nancy | |
| H？pital Pierre Wertheimer | France | Rhone-Alpes | Bron | |
| Berufsgenossenschaftliche Kliniken | Germany | Sachsen-Anhalt | Halle | |
| Charité – Universit？tsmedizin Berlin | Germany | Berlin | Berlin | |
| Klinikum der J.W. Goethe-Universit？t | Germany | Hessen | Frankfurt | |
| Klinikum Nürnberg | Germany | Bayern | Nürnberg | |
| Krankenhaus Merheim | Germany | Nordrhein-Westfalen | K？ln | |
| Niels-Stensen-Kliniken | Germany | Niedersachsen | Osnabrück | |
| Universit？tsklinikum Gie？en und Marburg gGmbH | Germany | Hessen | Marburg | |
| Universit？tsklinikum Hamburg-Eppendorf | Germany | Hamburg | Hamburg | |
| Universit？tsklinikum Heidelberg | Germany | Baden-Wuerttemberg | Heidelberg | |
| Universit？tsklinikum Ulm | Germany | Baden-Wuerttemberg | Ulm | |
| Universit？tsmedizin G？ttingen | Germany | Niedersachsen | G？ttingen | |
| Honvédelmi Minisztérium állami Egészségügyi K？zpont | Hungary | Budapest | Budapest | |
| Pécsi Tudományegyetem általános Orvostudományi Kar | Hungary | Baranya | Pécs | |
| Szegedi Tudományegyetem Szent-Gy？rgyi Albert Klinikai K？zpont | Hungary | - | Szeged | |
| Chaim Sheba Medical Center | Israel | - | Tel-Hashomer | |
| Hadassah Medical Organization | Israel | - | Jerusalem | |
| Rabin Medical Center | Israel | - | Petach-Tikva | |
| Rambam Medical Center | Israel | - | Haifa | |
| Tel Aviv Sourasky Medical Center | Israel | - | Tel Aviv | |
| Azienda Ospedaliera San Camillo Forlanini | Italy | - | Rome | |
| Azienda Ospedaliera San Gerardo | Italy | - | Monza | |
| Azienda Ospedaliero Universitaria Integrata di Verona | Italy | - | Verona | |
| Azienda Ospedaliero Universitaria Maggiore della Caritá | Italy | - | Novara | |
| zienda Ospedaliero Universitaria de Parma | Italy | - | Parma | |
| Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena | Italy | - | Milano | |
| Fondazione San Raffaele del Monte Tabor | Italy | - | Milano | |
| Ospedale Generale Regionale di Bolzano | Italy | - | Bolzano | |
| VU Medisch Centrum | Netherlands | Noord-Holland | Amsterdam | |
| Universitair Medisch Centrum Groningen | Netherlands | Groningen | Groningen | |
| Spitalul Clinic Judetean de Urgenta Timisoara | Romania | Timis | Timisoara | |
| Saint Petersburg Healthcare Institution “City Mariinsky Hospital” | Russia | - | St. Petersburg | |
| State Budget Educational Institution of Higher Professional Education “Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development” | Russia | - | Kemerovo | |
| State Budgeted Educational Institution of Higher Professional Education “Altai State Medical University” of Ministry of Health Care and Social Development of the Russian Federation | Russia | - | Barnaul | |
| State Educational Institution of High Professional Education “Bashkir State Medical University” | Russia | - | Ufa | |
| State Healthcare Facility “Murmansk Regional Clinical Hospital n.a. Bayandin” | Russia | - | Murmansk | |
| State Institution “Burdenko Neurosurgical Institute of RAMS” | Russia | - | Moscow | |
| State Institution of Health Care “Sverdlovsk Regional Clinical Hospital #1” | Russia | - | Yekaterinburg | |
| State Professional Institution of High Professional Education “Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development” | Russia | - | Krasnoyarsk | |
| Hospital Clínico Universitario De Valencia | Spain | - | Valencia | |
| Hospital General Universitario de Alicante | Spain | - | Alicante | |
| Hospital Parc Taulí | Spain | Barcelona | Sabadell | |
| Hospital Universitari i Politecnic La Fé de Valencia | Spain | - | Valencia | |
| Hospital Universitario de Bellvitge | Spain | - | Barcelona | |
| Hospital Universitario de Gran Canaria Dr. Negrín | Spain | - | Las Palmas de Gran Canaria | |
| Hospital Universitario 12 de Octubre | Spain | - | Madrid | |
| Hospital Universitario Germans Trias i Pujol | Spain | Barcelona | Badalona | |
| Hospital Universitario de Girona Dr. Josep Trueta | Spain | - | Girona | |
| Hospital Universitari Son Espases | Spain | Baleares | Palma de Mallorca | |
| Hospital Universitario del Valle de Hebrón | Spain | - | Barcelona | |
| Hospital Universitario Virgen del Rocio | Spain | - | Sevilla | |
| Leeds Teaching Hospitals NHS, Leeds General Infirmary | United Kingdom | England | Leeds | |
| 成都军区总医院 | 中国 | 四川 | 成都 | |
| 天津医科大学总医院 | 中国 | 天津 | 天津 | |
| 复旦大学附属华山医院 | 中国 | 上海 | 上海 | |
| 徐州医学院附属医院 | 中国 | 江苏 | 徐州 | |
| 福建医学院附属第一医院 | 中国 | 福建 | 福州 | |
| 上海交通大学医学院附属仁济医院 | 中国 | 上海 | 上海 | |
| 浙江大学医学院附属第二医院 | 中国 | 浙江 | 杭州 | |
| 山东大学第二医院 | 中国 | 山东 | 济南 | |
| Hospital Kuala Lumpur | Malaysia | Kuala Lumpur | Kuala Lumpur | |
| Hospital Raja Permaisuri Bainun | Malaysia | Perak | Ipoh | |
| Hospital Tengku Ampuan Afzan | Malaysia | Pahang | Kuantan | |
| Sarawak General Hospital | Malaysia | Sarawak | Kuching | |
| University Malaya Medical Centre | Malaysia | Kuala Lumpur | Kuala Lumpur | |
| National Neuroscience Institute | Singapore | Singapore | Singapore | |
| National University Hospital | Singapore | Singapore | Singapore | |
| Singapore General Hospital | Singapore | Singapore | Singapore | |
| National Taiwan University Hospital | 中国 | - | Taipei | |
| Taichung Veterans General Hospital | 中国 | - | Taichung | |
| Taipei Medical University – Wan Fang Hospital | 中国 | - | Taipei | |
| Hospital Central de Mendoza | Argentina | Mendoza | Mendoza | |
| Hospital Dr. José Maria Cullen | Argentina | Santa Fe | Santa Fe | |
| Hospital de Emergencias Clemente Alvarez (HECA) | Argentina | Santa Fe | Rosario | |
| Hospital Francisco Lopez Lima | Argentina | Rio Negro | General Roca | |
| Hospital Nacional “Profesor Alejandro Posadas” | Argentina | Buenos Aires | Buenos Aires | |
| Hospital Regional De Comodoro Rivadavia (HRCR) | Argentina | Chubut | Comodoro Rivadavia | |
| Hospital San Martin | Argentina | Entre Rios | Paraná | |
| Landesklinikum Wiener Neustadt | Austria | Lower Austria | Vienna | |
| Medizinische Universit？t Graz | Austria | Styria | Graz | |
| Medizinische Universit？t Innsbruck | Austria | Tyrol | Innsbruck | |
| Unfallkrankenhaus Salzburg | Austria | - | Salzburg | |
| ULB Erasme | Belgium | Brussels | Brussels | |
| Universitair Ziekenhuis Gent | Belgium | Oost-Vlaanderen | Gent | |
| University Hospital of the Free University Brussels (UZ Brussel) | Belgium | Brussels | Jette | |
| University Hospital Gasthuisberg | Belgium | Flemish Brabant | Leuven | |
| Ziekenhuis Oost-Limburg, Location Sint Jan | Belgium | Limburg | Genk | |
| Fakultní nemocnice Brno Neurochirurgická klinika | Czech Republic | - | Brno | |
| Fakultní nemocnice Královské Vinohrady | Czech Republic | - | Praha | |
| Fakultní nemocnice Plzeň, Neurochirurgicé odd？lení | Czech Republic | - | Plzeň | |
| Fakultní nemocnice u sv. Anny v Brn？, Neurochirurgická klinika | Czech Republic | - | Brno | |
| Tampere University Hospital | Finland | Western Finland | Tampere | |
| Centre Hospitalier Universitaire H？pital Nord | France | Provence Alpes Cote D’Azur | Marseille | |
| Centre Hospitalier Universitaire de Grenoble- Hópital Michallon | France | Rhone-Alpes | Grenoble | |
| Centre Hospitalier Universitaire de Limoges | France | Limousin, Lorraine | Limoges | |
| University of Oklahoma Medical Center | United States | Oklahoma | Oklahoma City | |
| Queen Elizabeth Hospital | United Kingdom | England | Birmingham | |
| Royal Preston Hospital | United Kingdom | England | Fulwood, Preston | |
| Southampton University Hospital | United Kingdom | England | Southampton | |
| The James Cook University Hospital | United Kingdom | England | Middlesbrough | |
| The Royal London Hospital | United Kingdom | England | London | |
| University Hospital Coventry | United Kingdom | England | Coventry | |
| University of South Alabama Medical Center | United States | Alabama | Mobile | |
| LAC+USC Medical Center | United States | California | Los Angeles | |
| University of California San Diego Medical Center | United States | California | San Diego | |
| Denver Health Medical Center | United States | Colorado | Denver | |
| Christiana Care Health System Hospital | United States | Delaware | Newark | |
| Delray Medical Center | United States | Florida | Delray Beach | |
| Tallahassee Memorial Healthcare | United States | Florida | Tallahassee | |
| Tampa General Hospital | United States | Florida | Tampa | |
| John H. Stroger, Jr., Hospital of Cook County | United States | Illinois | Chicago | |
| Advocate Lutheran General Hospital | United States | Illinois | Park Ridge | |
| Saint John’s Hospital | United States | Illinois | Springfield | |
| Wishard Health Services | United States | Indiana | Indianapolis | |
| Methodist Hospital | United States | Indiana | Indianapolis | |
| Mercy Medical Center | United States | Iowa | Des Moines | |
| University of Iowa Hospitals and Clinics | United States | Kansas | Iowa City | |
| University of Kansas Medical Center | United States | Kansas | Kansas City | |
| University of Louisville Clinical Research Center | United States | Kentucky | Louisville | |
| Eastern Maine Medical Center | United States | Maine | Bangor | |
| Maine Medical Center | United States | Maine | Portland | |
| Baystate Medical Center | United States | Massachusetts | Springfield | |
| University of Massachusetts Memorial Medical Center | United States | Massachusetts | Worcester | |
| Bronson Methodist Hospital | United States | Michigan | Kalamazoo | |
| University of Missouri Health Care | United States | Missouri | Columbia | |
| Lester E. Cox Memorial Hospital | United States | Missouri | Springfield | |
| Nebraska Medical Center | United States | Nebraska | Omaha | |
| Robert Wood Johnson University Hospital | United States | New Jersey | New Brunswick | |
| Albany Medical Center Hospital | United States | New York | Albany | |
| New York Medical College | United States | New York | Valhalla | |
| Mission Hospital | United States | North Carolina | Asheville | |
| Carolinas Medical Center | United States | North Carolina | Charlotte | |
| Duke University Medical Center | United States | North Carolina | Durham | |
| Wake Forest University-Baptist Medical Center | United States | North Carolina | Winston-Salem | |
| Summa Health System | United States | Ohio | Akron | |
| MetroHealth Medical Center | United States | Ohio | Cleveland | |
| Miami Valley Hospital | United States | Ohio | Dayton | |
| Saint Elizabeth Health Center | United States | Ohio | Youngstown | |
| CHRU de Lille- Hópital Roger Salengro | France | Nord Pas-de-Calais | Lille | |
| Groupe Hospitalier La Salpêtrière | France | Ile-de-France | Paris | |
| Legacy Emmanuel Hospital | United States | Oregon | Portland | |
| University of Pittsburgh Medical Center | United States | Pennsylvania | Pittsburgh | |
| Allegheny General Hospital | United States | Pennsylvania | Pittsburgh | |
| Medical University of South Carolina | United States | South Carolina | Charleston | |
| Palmetto Clinical Trial Services | United States | South Carolina | Columbia | |
| Johnson City Medical Center | United States | Tennessee | Johnson City | |
| Vanderbilt University Medical Center | United States | Tennessee | Nashville | |
| University Medical Center of El Paso | United States | Texas | El Paso | |
| University of Virginia Health System | United States | Virginia | Charlottesville | |
| Cabell Huntington Hospital | United States | West Virginia | Huntington | |
| West Virginia University Hospital | United States | West Virginia | Morgantown | |
| University of Wisconsin Hospital and Clinics | United States | Madison | Wisconsin |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| na | 2011-06-23 |
试验状态信息
试验状态
进行中-招募中
目标入组人数
已入组例数
国际: 登记人暂未填写该信息；
实际入组总例数
国际: 登记人暂未填写该信息；
第一例受试者签署知情同意书日期
国际：登记人暂未填写该信息；
第一例受试者入组日期
国际：登记人暂未填写该信息；
试验终止日期
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
