ISRCTN92114384进行中（未招募）3 期
PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY (PROPHESY-2 trial): a phase III, randomised control trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 496
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
- •1. Age =18 years
- •2. Undergoing cardiac surgery (Elective and Urgent procedures) not described in the exclusion criteria
排除标准
- •1. Emergency and Salvage procedures (as per definitions in section 6.0)
- •2. First-time isolated coronary artery bypass graft (CABG) surgery given the low risk of significant bleeding
- •3. First time isolated aortic valve replacement (excluding active endocarditis)
- •4. First time isolated mitral valve replacement
- •5. Surgeries that do not involve cardiopulmonary bypass
- •6. Heart transplant
- •7. Use of warfarin within 3 days prior to surgery
- •8. Use of direct oral anticoagulants (i.e. dabigatran, rivaroxban, apixaban or edoxaban etc) within 48 hours prior to surgery (or 72 hours if patient has renal impairment – i.e. estimated glomerular filtration rate of <30 ml/min)
- •9. Any contraindication to PCC or FFP or LG-Octaplas, for example: known or suspected allergy to heparin, Sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate and Glycine, History of Heparin-induced thrombocytopenia, history of blood transfusion reaction due to IgA deficiency with known antibodies against IgA
- •10. Patients refusing blood transfusion for any reason
- •11. Inherited bleeding disorder (i.e. any inherited clotting factor deficiencies, or platelet disorders)
- •12. Pregnancy as PCC is contraindicated
- •13. Documented thrombophilia defects (antiphospholipid syndrome, severe protein S deficiency, antithrombin deficiency)
- •14. Documented venous thromboembolism in the last 3 months prior to surgery
- •15. Patients who are expected to require Extracorporeal Membrane Oxygenation after cardiac surgery
- •16. Patient previously randomised into this trial and has not reached 90 days post randomisation
研究者
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