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临床试验/CTRI/2024/10/075225
CTRI/2024/10/075225尚未招募不适用

Comparison of Hemostatic parameters in patients with and without transfusion of Residual pump blood following Protamine administration in Valve replacement surgeries

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
The outcome measures is to assess the post operative chest tube drains, need of blood transfusion and re-exploration.

研究概览

简要总结

This study is done to compare the haemostatic parameters  in patients with or without transfusing the residual pump blood following protamine administration in valve replacement surgeries and it is performed to determine the safety and efficacy of transfusing unprocessed residual pump blood post protamine administration in valve replacement surgeries. This proposed study can further reduce the allogeneic blood transfusion in post operative period and reduces the complication caused by it, and it would further help to clarify whether this approach poses an increased bleeding risk or can be a safe alternative to homologous blood transfusion.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • • Elective adult cardiac surgeries undergoing cardiopulmonary bypass in Isolated Single Valve Replacement Surgeries • Group A.
  • Male patients having Hb less than 10g/dL and female patients having Hb less than 9g/dL are considered • Group B.
  • Male patients having Hb more than 10g/dL and female patients having Hb more than 9g/dL are considered.

排除标准

  • • Emergency cardiac surgeries • Redo Surgeries • Patients below 18 years and patients above 70 years • Patients on oral anticoagulation • Anemic Patients • Pre-existing coagulopathy disorder.

结局指标

主要结局

The outcome measures is to assess the post operative chest tube drains, need of blood transfusion and re-exploration.

时间窗: 1year

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nireeksha

Manipal College of Health Professions

研究点 (1)

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