Post-Operative Thrombocytopenia After Bio-prosthesis Implantation (PORTRAIT Study): a Retrospective International Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,233
- 试验地点
- 1
- 主要终点
- Platelet count
研究概览
简要总结
The objective of the study is to obtain the clinical data from patients who received a biological prosthesis in aortic or mitral position, in order to evaluate the occurrence of peri-operative thrombocytopenia.
The aim of the study is to analyze the eventual clinical impact of the phenomenon (re-operation for bleeding, blood transfusion) and the mortality rate.
This is a multicentre retrospective, observentional clinical study. This study will enroll up to 5000 patients since 2000 to date.
详细描述
Cardiac surgery is commonly associated with a transient post-operative decrease in the platelet count. Thrombocytopenia after cardiopulmonary bypass can be explained by hemodilution, exposure to artificial surfaces with platelet activation and adhesion, hypothermia, blood loss and mechanical sequestration. It usually occurs between the second and third postoperative days, resulting in a reduction of platelet counts by 40-50% from baseline values. Moreover, when a foreign body as a valve prosthesis is literally placed into the blood flow, blood cells are constantly exposed to its surface and eventually inflammatory and, perhaps, autoimmune reactions could start. The interactions biomaterial-blood induce changes in platelet shape, metabolism as well as receptor-mediated dysfunction and lysis. Then, any significant decline in the circulating platelet count raises concerns about coagulation disorders and bleeding.
Despite the advanced hemodynamic performance, recently thrombocytopenia (defined as nadir platelet count < 150.000 x 1000/uL) has been associated to new aortic biological prostheses, either rapid deployment or trans-catheter valves. Although several studies have been carried on, the drop in the platelet count after aortic valve replacement with certain tissue valves remains unexplained yet. The decrease after the valve implantation, however, is not exclusively limited to the surgical prostheses. Trans-catheter aortic valves, in fact, were found to be associated to post-procedure thrombocytopenia. Thrombocytopenia following transcatheter aortic valve implantation (TAVI) procedures is related to the increased adverse events rate such as death, stroke, acute kidney injury, bleeding and vascular complications. Furthermore, thrombocytopenia seems to occur most likely associated after balloon-expandable valves implantation.The literature, however, is confounding.
Despite several studies, little is known about the mechanism involved. Variations in biocompatibility of valve tissue as like a strong immune/inflammatory response could be some explanations. However, there is still uncertainty about the mechanism conditioning post-operative platelet drop. To address this uncertain the underlying process should be evaluated in a large multicentre trial.
The aims of the study are the following:
- to analyze the occurrence of thrombocytopenia after isolated aortic valve replacement/implantation and after isolated mitral valve replacement;
- to evaluate the clinical impact of thrombocytopenia (length of stay, bleeding, re-operation for bleeding, blood transfusion, mortality).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing isolated aortic valve replacement/implantation or isolated mitral valve replacement with a biological prosthesis.
排除标准
- •Pre-existent thrombocytopenia;
- •Oncologic diseases;
- •Pre-existent infections/inflammations;
- •Use of drugs inducing thrombocytopenia (<3months);
- •Combined cardiac surgery operations;
- •Recent percutaneous cardiac intervention (<1month).
结局指标
主要结局
Platelet count
时间窗: 1-3months follow-up
to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis
Re-exploration for bleeding
时间窗: From the index procedure up to 3 months
to determine the low platelets-related complication rate
packed Red Cells transfusion, fresh frozen plasma transfusion, Platelet transfusion
时间窗: During the index hospital stay, an average of 5 days
to determine the low platelets-related complication rate
Major bleeding (requiring more than 2 Red blood cells transfusions)
时间窗: From the index procedure up to 3 months
to determine the low platelets-related complication rate
次要结局
- 30-day mortality(within 30 days)
- Gastro-intestinal bleeding(From the index procedure within 3 months)
- In-hospital mortality(Participants are followed during the duration of hospital stay (expected: up to 7 days post-op))
- In-hospital length of stay(From the index procedure through discharge from the hospital (expected: up to 7 days post-op))
- ICU length of stay(From the index procedure through discharge from the Intensive Care Unit (expected: up to 2 days post op))
- Intracranial Bleeding(From the index procedure within 3 months)
- Thrombosis(From the index procedure within 3 months)