Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Correlation of Quantra with Prothrombin Time and Activated Clotting Time in patients presenting with acute bleeding in the operating room
研究概览
简要总结
The goal of this observational study is to assess the correlation between Quantra viscoelastometric assay and laboratory hemostasis biology in a cardiac surgery cohort presenting with acute hemorrhage in the operating room. The main questions it aims to answer are:
- is Quantra a valuable surrogate for hemostasis biology in the setting of bleeding cardiac surgery?
- are Quantra parameters well correlated with tranfusion thresholds in the setting of bleeding cardiac surgery?
详细描述
This observational study aims to assess the relevance of Quantra use in the setting of cardiac surgery patients presenting with acute bleeding in the operating room.
Hemorrhage is frequent in cardiac surgery. In the setting of per-operative acute bleeding, patient management and transfusions require a meticulous approach as both under-treatment and over-treatment can concur to morbidity and mortality. In this specific setting, the short timeframe of management usually does not allow usual laboratory tests (prothrombin time, activated clotting time, fibrinogen and platelets counts) to be integrated in the decision-making process. Viscoelastic hemostatic assays (VHA) such as Quantra might be relevant in this setting, owing to point-of-care bedside features.
As part of usual care for patients undergoing cardiopulmonary bypass for cardiac surgery at the Pitié-Salpêtrière Hospital, the investigators use Quantra viscoelastometric tests in various situations , including for per-operative hemorrhage management. Yet, it appears Quantra relevance has never been challenged in this population.
The investigators seek to determine whether in a population of patients presenting with significant hemorrhage in the operating room of cardiac surgery Quantra parameters (CT, CTH, FCS and PCS) are well-correlated to standard biology testing (prothrombin time, activated clotting time, fibrinogen and platelets count) and to transfusion thresholds.
Universal Definition of Perioperative Bleeding (UDPB) is a widely used quantification of bleeding in cardiac surgery. Nonetheless, most of its parameters of interest are assessed post-operatively and definition of acute bleeding during cardiac surgery lack. The investigators propose different bleeding definitions to assess hemorragic intra-operative events: 5 or more labile blood products transfused after protamine administration, and a modified UDPB definition to properly match significant per-operative bleeding events. The modified UDPB definition of interest will classify patients presenting with severe hemorrhage, patients presenting with massive hemorrhage as following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Source population:
- •Consecutive patients undergoing cardiac surgery with cardiopulmonary bypass
- •Inclusion Criteria:
- •cardiac surgery with cardiopulmonary bypass, either scheduled or urgent
- •adult patient
- •hemostatic assay including Quantra and standard biology (PT, ACT, fibrinogen concentration and platelet count) at cardiopulmonary bypass weaning (post-protamine)
排除标准
- •- non-opposition for participation not collected
研究组 & 干预措施
Monocentric consecutive patients undergoing cardiac surgery
Monocentric consecutive patients undergoing cardiac surgery, tested for biological hemostasis during surgery with both viscoelastometric assay (Quantra Qplus) and QT, ACT, fibrinogenemia, platelet count.
干预措施: Viscoelastometric hemostatic assay (Diagnostic Test)
结局指标
主要结局
Correlation of Quantra with Prothrombin Time and Activated Clotting Time in patients presenting with acute bleeding in the operating room
时间窗: From enrollment to 1 month post-operatively
In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Clotting Time without or with Heparinase (CT / CTH) with Prothrombin Time (PT) and Activated Clotting Time (ACT), all measured in seconds
Correlation of Quantra with fibrinogen concentration in patients presenting with acute bleeding in the operating room
时间窗: From enrollment to 1 month post-operatively
In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Fibrinogen contribution to Clot Stiffness (FCS), in hPa, and patient's blood fibrinogen concentration in g/L
Correlation of Quantra with platelet count in patients presenting with acute bleeding in the operating room
时间窗: From enrollment to 1 month post-operatively
In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Platelet contribution to Clot Stiffness (PCS), in hPa, and patient's platelet count in G/L
次要结局
- Correlation of Quantra with fibrinogen concentration in patients without bleeding(From enrollment to 1 month post-operatively)
- Correlation of Quantra with Prothrombin Time (PT) and Activated Clotting Time (ACT) in patients without bleeding(From enrollment to 1 month post-operatively)
- Correlation of Quantra with platelet count in patients without bleeding(From enrollment to 1 month post-operatively)
- Correlation between Quantra and prothrombin time transfusion threshold in patients presenting with hemorrhage in cardiac surgery(From enrollment to 1 month post-operatively)
- Correlation between Quantra and fibrinogen concentration transfusion thresholds in patients presenting with hemorrhage in cardiac surgery(From enrollment to 1 month post-operatively)
- Correlation between Quantra and platelet count transfusion thresholds in patients presenting with hemorrhage in cardiac surgery(From enrollment to 1 month post-operatively)
研究者
Marquet Yann
Medical Doctor
Pitié-Salpêtrière Hospital