NCT04807621Unknown2 期
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.
Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HEPTEM-A10
研究概览
简要总结
The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass.
- •Body weight < 10 kg.
- •Expected CPB time > 90 minutes.
排除标准
- •Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patient´s age), gestational age < 34 weeks.
结局指标
主要结局
HEPTEM-A10
时间窗: 45 minutes after intervention
The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.
次要结局
- Amount of transfused packed red blood cells(up to first postoperative morning)
研究者
Fredrik Söderlund
Consultant, Anaesthesia and Intensive Care
Sahlgrenska University Hospital, Sweden
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Double Closure of Nasal Layer in Alveolar Cleft GraftingAlveolar CleftNCT05988086Tanta University24
已完成
不适用
Platelet Rich Fibrin in the Treatment of Multiple Gingival RecessionsGingival RecessionNCT02018120Ege University26
尚未招募
3 期
Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger TreatmentTrigger Finger DisorderNCT06532318Obafemi Awolowo University Teaching Hospital40
已完成
不适用
Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla ReconstructionTo Evaluate the Efficacy of Platelet-rich Fibrin in Papilla ReconstructionTo Evaluate the Efficacy of Connective Tissue Graft in Papilla ReconstructionNCT05207696Hacettepe University55
Unknown
1 期
The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant StabilityDental ImplantsNCT03044119KLE Society's Institute of Dental Sciences15