CTRI/2020/07/026319尚未招募3 期
Comparison between Intermittent Bolus versus Continuous Intravenous Infusion of Tranexamic Acid in Haematological Disorders with Thrombocytopenia - BRAVE
CMC Ludhiana0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Subjects will be eligible for the trial if they have a confirmed diagnosis of one of the following hematological disorders and with a platelet count below 20000/cumm and those who are willing to give consent.
- •1.Acute myeloid leukemia
- •2.Acute lymphoblastic leukemia
- •3.Aplastic anemia
- •4.Immune thrombocytopenia
排除标准
- •1. Patients with a previous history or current diagnosis of arterial or venous thromboembolic disease, including myocardial infarction, peripheral vascular disease and retinal arterial or venous thrombosis;
- •2. Diagnosis of acute promyelocytic leukemia and undergoing induction chemotherapy
- •3. Diagnosis/history of veno-occlusive disease (VOD) (also called
- •sinusoidal obstruction syndrome)
- •4. Known inherited or acquired prothrombotic disorders.
- •5. Thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome
- •6. Overt disseminated intravascular coagulation
- •7. Known inherited or acquired bleeding disorder, such as acquired storage pool deficiency
- •8. Paraproteinaemia with platelet inhibition receiving anti-coagulant therapy or antiplatelet therapy
- •9. Visible haematuria at time of randomisation
- •10. Anuria (defined as urine output of less than 10 mL/h over 24 h)
- •11. Severe renal impairment (estimated glomerular filtration rate of not more than 30 mL/min per 1.73 m2)
- •12. History of epilepsy, convulsions, fits or seizures
- •13. Pregnant or breast-feeding
- •14. Allergic to TXA, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
研究者
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