CTRI/2021/06/034500招募中未知
A Real-world, prospective, multicentre, observational, investigator-initiated study to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB).
Artemis Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
入选标准
- •Patients meeting with following criteria to be included from the study:
- •1) Neonates of both gender.
- •2) Neonates who are scheduled to undergo cardiac surgery
- •involving cardiopulmonary bypass with CAPIOX FX05
- •integrated arterial filter oxygenator.
- •3) Legally acceptable representatives of neonates willing
- •to sign an Informed Consent Form indicating that they
- •understand the purpose of and the procedures required
- •for the study and are willing to participate in the
排除标准
- •Patients meeting with following criteria to be excluded from the study:
- •1) Neonates who are diagnosed with Cyanotic Heart Disease.
- •2) Neonates who are or will be on cardiopulmonary bypass for
- •more then 2 hours.
- •3) Presence of any other clinically significant disease or
- •laboratory findings that in the investigators opinion may
- •affect the study outcomes.
- •4) Participation in another study concurrently or within 4
- •weeks prior to the Screening visit.
研究者
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