ISRCTN13973041进行中（未招募）Unknown
A retrospective chart review study evaluating clinical practice, treatment patterns and outcomes of four-factor prothrombin complex concentrates (4F-PCC) in patients treated with Factor Xa (FXa) inhibitors prior to surgery or invasive procedure and those requiring on-demand reversal for a major bleed
Takeda (United States)0 个研究点目标入组 400 人开始时间: 2024年1月29日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Surgery indication:
- •1. Patient was >18 years of age at the time of surgery/invasive procedure
- •2. Patient was on treatment with an oral FXa inhibitor (rivaroxaban, apixaban, edoxaban) at time of surgery/invasive procedure
- •3. Patient admitted for a high-bleeding risk surgery (e.g., intra-abdominal surgery [e.g., bowel or visceral organ resection]), intra-thoracic surgery (e.g., lung resection), major orthopedic surgery (e.g., hip/knee replacement], arterial revascularization (e.g., abdominal aortic aneurysm repair, vascular bypass), urologic surgery (e.g., prostatectomy, bladder tumor resection), any other surgery lasting = 1 hour, or major invasive procedure with high bleeding risk (e.g., colonic polyp resection, biopsy of kidney or prostate)
- •4. Patient received Takeda PROTHROMPLEX TOTAL or other 4F-PCC (e.g., Beriplex/Kcentra, Octaplex, Cofact, Uman Complex, Kanokad, Kedcom) reversal infusion during surgery or an invasive procedure as their first reversal agent type to control intra-operative bleeding in patients admitted for surgery/invasive procedure
- •Major bleed indication:
- •1. Patient was >18 years of age at time of admission for an acute major bleed
- •2. Patient was on treatment with an oral FXa inhibitor (rivaroxaban, apixaban, edoxaban) at the time of major bleed
- •3. Patient received a 4F-PCC reversal infusion (e.g., Beriplex/Kcentra, Octaplex, PROTHROMPLEX TOTAL, Cofact, Uman Complex, Kanokad, Kedcom) for a major bleed as their first on-demand reversal agent type
- •4. Acute major bleeding, defined as bleeding that is potentially life-threatening, that requires an emergent surgery or invasive procedure, or requires transfusion of =1 units of PRBCs or is associated with a decrease in Hg of >2.0 g/dL, or bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial. Acute bleeding associated with a Hg level of =8 g/dL if no baseline Hg is available is also considered major.
排除标准
- •Surgery indication:
- •Cohort 1: Real-world patients undergoing reversal with 4F-PCC
- •1. Patient presented with an acute bleed that required on-demand therapy with 4F-PCC
- •2. Patient underwent a low-bleeding risk surgery/invasive procedure (gastrointestinal endoscopy [with or without biopsy], cardiac catheterization [with or without percutaneous coronary intervention], permanent pacemaker or internal defibrillator insertion, dental surgery or other dental procedure, dermatologic surgery or other dermatologic procedure, cataract removal or other ophthalmologic procedure, any other surgery or procedure lasting < 1 hour)
- •3. Participation in a clinical study involving an investigational product or device within 30 days prior to or after initiation of 4F-PCC reversal
- •Bleeding indication:
- •Cohort 2: Real-world patients undergoing on-demand reversal with 4F-PCC for major bleeding
- •1. Patient with acquired/congenital hemostatic disorders, e.g., hemophilia A and B, platelet function disorder, fibrinogen deficiency, Von Willebrand disease, coagulation factor deficiency, acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C (1)), confirmed or suspected sepsis
- •2. Patient with minor bleeding (e.g., epistaxis, hematuria)
- •3. Peri-operative reversal with 4F-PCC to control intra-operative bleeding in patients admitted for surgery/invasive procedure
- •4. Participation in a clinical study within 30 days post initiation of 4F-PCC on-demand reversal
研究者
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