Transfusion of Plasma Prior to Invasive Procedures Pilot Trial (TOPPIT)
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Recruitment feasibility, as measured by the number of participants screened per month at each center.
研究概览
简要总结
Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or incision). The most frequent group that requires FP transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also frequently require invasive medical procedures that can be associated with bleeding. While FP transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic FP transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, it is known that important adverse complications occur with FP transfusions.
The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP transfusion or no treatment prior to an invasive procedure.
The primary outcome for this pilot study will be feasibility (the number of patients enrolled per month). Other important outcomes will include those that will be evaluated in the definitive trial including bleeding post procedure, red cell transfusions, adverse transfusion reactions, mortality and hospital length of stay.
The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.
详细描述
There are 3 accepted indications for transfusing FP:
- bleeding in patients with prolonged coagulation tests that cannot be corrected with other products or medications,
- prior to surgery or invasive procedures in patients who have prolonged coagulation test that cannot be corrected with other products or medications and
- plasmapheresis for Thrombotic Thrombocytopenia Purpura.
While the indications for FP seem relatively straightforward, there are still large variations in use and important inappropriate use. This is due to the lack of properly conducted studies evaluating the true risk of bleeding in patients with an abnormal coagulation tests and, as a consequence, a lack of knowledge about the true benefits or harms of transfusing FP to reduce bleeding.
The current paradigm for the use of FP to treat or prevent bleeding is based on the following assumptions:
- elevated coagulation tests represent a decrease in coagulation factors that will contribute to bleeding,
- FP transfusions will increase the levels of coagulation factors and correct the coagulation test abnormalities,
- the correction of the coagulation test abnormality will decrease bleeding. However, there is a lack of evidence to support each of the assumptions in this paradigm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or greater
- •Admission or planned admission (e.g. patients in emergency department who are being seen by the ICU team) to an intensive care unit.
- •An elevated INR between 1.5 and 2.
- •Requiring an invasive procedure in the next 24 hours including central venous line, arterial line, paracentesis, thoracocentesis, bronchoscopy, endoscopy, and ultrasound guided biopsy (mass or organ) or fluid drainage.
排除标准
- •Active bleeding, defined as visible or suspected blood loss in last 48 hours, resulting in a fall in hemoglobin greater than or equal to 20 g/L, requiring a red cell transfusion or an intervention to control bleeding.
- •Full dose therapeutic anticoagulation with warfarin, heparin, low molecular weight heparin, or other novel oral anticoagulants.
- •Congenital bleeding disorders including hemophilia, von Willebrand Disease or platelet function disorders.
- •Acquired coagulation factor deficiencies.
- •Frozen plasma transfusion during this ICU admission.
- •Use of other hemostatic blood products (recombinant factor VIIa, prothrombin complex concentrate, cryoprecipitate, fibrinogen concentrate) during the ICU admission
- •Previously enrolment in the study.
- •Patients will not be excluded for thrombocytopenia or anti-platelet drugs. As a pilot trial for a pragmatic large randomized controlled trial, both thrombocytopenic patients and patients on anti- platelet agents will be enrolled as they are routinely encountered in clinical practice. Specific therapy (i.e. platelet transfusions) will not be mandated, but left to local routine practice. Information regarding platelet counts, anti-platelet medications, platelet transfusions and other hemostatic therapies will be collected.
研究组 & 干预措施
FP Transfusion
patients randomized to receive frozen plasma transfusions
干预措施: Frozen plasma (Biological)
no FP Transfusion
patients not receiving frozen plasma transfusions
结局指标
主要结局
Recruitment feasibility, as measured by the number of participants screened per month at each center.
时间窗: monthly, up to 21 months
次要结局
- ICU length of stay(ICU length of stay will be measured as the number of days elapsed between Intensive Care Unit admission and discharge dates up to 21months.)
- Bleeding assessment (Changes in hemoglobin and red cell transfusions as measured by a standardized bleeding assessment tool)(24-48 hours post-procedure)
- Ventilator requirement(24-48 hours post frozen plasma transfusion)
- Overall length of stay(Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 21 months.)