EUCTR2013-000909-24-NL进行中（未招募）1 期
OPTI-CLOT:Peri-Operative PharmacokineTIc-guided dosing of CLOTting factor in Hemophilia. - OPTICLOT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Severe and moderate hemophilia A or B (FVIII/FIX plasma level = 5%)
- •- Elective and low or medium risk surgery as defined by surgical risk score (form B)
- •- = 12 years of age at inclusion date for the randomized controlled trial;
- •- < 12 years of age at inclusion date for the PK-guided dosing observational children cohort.
- •- Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 72
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with other congenital or acquired hemostatic abnormalities.
- •- Withdrawal of (parental) informed consent.
- •- Detectable FVIII/FIX inhibiting antibodies (>0.02 BU) at inclusion in study.
- •- General medical conditions which may interfere with participation in the study.
研究者
相似试验
已完成
不适用
OPTI-CLOT: Peri-OPerative pharmacokineTIc-guided dosing of CLOTting factor in hemophiliaabnormal clot formationbleeding disorder10005330NL-OMON47823Erasmus MC, Universitair Medisch Centrum Rotterdam66
已完成
不适用
Peri -and postoperative drug therapy schedules for morbidly obese patientsmorbide obesitasextreme obesityMorbid obesityNL-OMON33325Sint Antonius Ziekenhuis20
已完成
3 期
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the EsophagusEsophageal Adenocarcinoma (UICC TNM7)Adenocarcinoma of the Esophagogastric JunctionC15Malignant neoplasm of oesophagusDRKS00008008niversity Hospital Schleswig-Holstein438
进行中（未招募）
1 期
Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus - ESOPECHistologically proven adenocarcinoma of the esophagus according to the Union internationale contre le cancer (UICC) TNM7 definition. Both tumors of the esophagus and tumors of which the epicentre is within 5 cm of the esophagogastric junction and also extend into the esophagus can be included into the trial in case of adenocarcinomatous histology.MedDRA version: 21.1Level: LLTClassification code 10026180Term: Malignant neoplasm of oesophagusSystem Organ Class: 100000004864EUCTR2015-001683-20-DEniversitätsklinikum Schleswig-Holstein, Campus Lübeck438
进行中（未招募）
不适用
Preoperative administration of controlled-release oxycodone vs morphine as transition oppioid for TIVA in pain control post VATS - NDPatients subjects at VATS for spontaneus pneumothoraxMedDRA version: 9.1Level: LLTClassification code 10062043Term: Lung operationEUCTR2008-002662-56-ITAZIENDA OSPEDALIERA DI PARMA