ISRCTN79371664进行中（未招募）未知
The Threshold for Platelets (T4P) study: a prospective randomised trial to define the platelet count below which critically ill patients should receive a platelet transfusion prior to an invasive procedure
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 2,550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 17/03/2023:
- •1. Adult (aged 18 years or older)
- •2. Accepted for admission or admitted to a participating critical care unit
- •3. Platelet count <50 x 10e9/l
- •4. Planned to undergo a specified* low bleeding risk invasive procedure OR platelet transfusion being considered for an 'other' procedure
- •*Specified low bleeding risk invasive procedures include the following:
- •1. Central venous vascular catheter insertion (including vascular access for renal replacement therapy)
- •2. Paracentesis/superficial abdominal fluid collection drainage
- •3. Pleural aspiration
- •‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure and a platelet transfusion is being considered for the procedure. These include, but are not limited to, the following:
- •1. Arterial catheter insertion
- •2. Arterial or central venous catheter removal
- •3. Pleural drain
- •4. Interventional radiology (as defined by Society of Interventional Radiology guidelines)
- •5. Bronchoscopy with or without lavage
- •6. Wound dressing changes
- •7. Surgical procedures where the clinical team agree the risk of bleeding is low, e.g. re-look laparotomy, or wound closure
- •Previous participant inclusion criteria:
- •1. Adult (aged 18 years or older)
- •2. Accepted for admission or admitted to a participating critical care unit
- •3. Platelet count <50 x 10e9/l
- •4. Platelet transfusion being considered for a low bleeding risk invasive procedure*
- •*Low bleeding risk invasive procedures include the following:
- •1. Vascular catheter insertion and removal (central venous – including vascular access for renal replacement therapy)
- •2. Paracentesis/superficial abdominal fluid collection drainage
- •3. Pleural aspiration
- •‘Other’ procedures may be included if the clinician deems these to be a low bleeding risk invasive procedure. These include, but are not limited to, the following:
- •1. Arterial catheter line insertion
- •2. Pleural drain
- •3. Interventional radiology (as defined by Society of Interventional Radiology guidelines)
- •4. Bronchoscopy with or without lavage
- •5. Wound dressing changes
- •6. Surgical procedures where the clinical team agree risk of bleeding is low, e.g. re-look laparotomy, or wound closure
排除标准
- •Current participant exclusion criteria as of 17/03/2023:
- •1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention*
- •2. Intercranial haemorrhage within prior 72 hours*
- •3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects)
- •4. Acute promyelocytic leukaemia (APML)
- •5. Known advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses)
- •6. Death perceived as imminent or admission for palliation
- •7. Previously randomised into T4P
- •8. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours
- •*Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for
- •Previous participant exclusion criteria:
- •1. Ongoing major haemorrhage requiring blood products and/or surgical/radiological intervention*
- •2. Intercranial haemorrhage within prior 72 hours*
- •3. Contra-indication to platelet transfusion (such as thrombotic microangiopathies; heparin-induced thrombocytopaenia; immune thrombocytopaenia; congenital platelet function defects)
- •4. Advance decision refusing blood/blood component transfusions (e.g. Jehovah’s Witnesses)
- •5. Death perceived as imminent or admission for palliation
- •6. Previously randomised into T4P
- •7. Fulfilled all the inclusion criteria and none of the other exclusion criteria =72 hours
- •*Exclusion criteria no. 1 and 2 are dynamic, and if resolved, the patient may be reconsidered for the trial
研究者
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