EUCTR2011-004139-29-AT进行中（未招募）不适用
RETIC trial: Reversal of Trauma Induced Coagulopathy by using Coagulation factor concentrates or Fresh frozen Plasma
Medizinische Universität Innsbruck / UK für Anästhesie und Intensivmedizin & UK für Allgem. u. Chirurg. Intensivmedizin0 个研究点开始时间: 2011年11月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •I.1. Male and female subjects ? 18 years and < 80 years
- •I.2. Major trauma (ISS>15)
- •I.3. Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient
- •I.4. Presence of coagulopathy defined by ROTEM assays as follows,
- •o Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of <7 mm after 10 min)
- •o Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of >90 sec)
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •E.1. Lethal injury
- •E.2. CPR on the scene,
- •E.3. Isolated brain injury, burn injury
- •E.4. Avalanche injury
- •E.5. Administration of FFP or coagulation factor concentrates before ED admission
- •E.6. Delayed (>6hours after trauma) admittance to ED
- •E.7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury
- •E.8. Known history of severe allergic reaction to plasma products
- •E.9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency
- •E.10.Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year
- •E. 11. Patients with a body weight <45kg and >150kg
- •E.12. Patients that are known to be pregnant
- •E.13. Jehova‘s Witness
- •E.14. known participation in another clinical trial
- •E.15. Patient with known refusal of a participation in this clinical trial
研究者
相似试验
终止
3 期
RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen PlasmaMajor TraumaNCT01545635Medical University Innsbruck100
已完成
Unknown
Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysisJPRN-UMIN000050170Department of Emergency Medicine, Hokkaido University Hospital
已完成
不适用
Coagulopathy and damage control resuscitation during transfer due to massive hemorrhage following traumaJPRN-UMIN000043961Teine Keijinkai Hospital41
已完成
不适用
Acute coagulopathy and inflammation of traumacoagulopathyNL-OMON39604Academisch Medisch Centrum500
进行中（未招募）
1 期
RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over TrialChronic Kidney DiseaseEUCTR2018-003232-80-FRASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE40