EUCTR2021-000990-10-FR进行中（未招募）1 期
FORMAT Study : Use of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion - evaluation by rotem viscoelastometry (pilot single-center study) - FORMAT
Institut de Cancérologie Lucien Neuwirth0 个研究点目标入组 10 人开始时间: 2021年3月9日最近更新:
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
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Major patient;
- •- Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation;
- •- Grade = 1 hemorrhagic symptom according to WHO - WHO classification;
- •- Body weight between 38 and 78 kg;
- •- Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI);
- •- Patient affiliated to a social security scheme
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Patient who expressed his opposition to participating in the study;
- •- Pregnant or breastfeeding woman;
- •- Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
- •- Patient with non-malignant hematological involvement;
- •- Patient with a high plasma fibrinogen concentration (> 5g / L);
- •- Patient allergic to fibrinogen;
- •- Patient with disseminated intravascular coagulopathy;
- •- Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant).
研究者
相似试验
已完成
不适用
Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleedingMassive bleeding during 1)Pregnancy and delivery 2)Cardiovascular surgery 3)Gastrointestinal (including hepato-biliary-pancreatic) surgeryJPRN-UMIN000022666Kagoshima University Hospital, Division of blood transfusion medicine and cell therapy26
已完成
不适用
Randomised controlled trial of fibrinolytic aided pleural drainage during chemical pleurodesis for malignant pleural effusioMalignant pleural effusionCancerISRCTN31343854Department of Health40
进行中（未招募）
1 期
Fibrinogen concentrate to treat bleeding at the time of childbirthPostpartum haemorrhageMedDRA version: 14.1 Level: LLT Classification code 10036294 Term: Postpartum haemorrhage (primary) System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 14.1 Level: LLT Classification code 10043454 Term: Third-stage postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 14.1 Level: PT Classification code 10036417 Term: Postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 14.1 Level: PT Classification code 10043449 Term: Third stage postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsEUCTR2012-005511-11-GBRACD Cardiff University57
进行中（未招募）
不适用
REPLACE (Randomized evaluation of fibrinogen versus placeboin complex cardiovascular surgery): a prospective, multinational,multicenter, randomized, double-blind, placebo-controlled, phaseIII study for the use of Fibrinogen Concentrate (Human) (FCH) incomplex cardiovascular surgeryAcute bleeding while undergoing aortic replacement surgeryMedDRA version: 14.1Level: LLTClassification code 10049052Term: Aortic surgery NOSSystem Organ Class: 100000004865EUCTR2011-002685-20-PLCSL Behring GmbH152
进行中（未招募）
不适用
REPLACE (Randomized evaluation of fibrinogen versus placeboin complex cardiovascular surgery): a prospective, multinational,multicenter, randomized, double-blind, placebo-controlled, phaseIII study for the use of Fibrinogen Concentrate (Human) (FCH) incomplex cardiovascular surgeryAcute bleeding while undergoing aortic replacement surgeryMedDRA version: 14.1Level: LLTClassification code 10049052Term: Aortic surgery NOSSystem Organ Class: 100000004865EUCTR2011-002685-20-FICSL Behring GmbH152