Health Condition 1: D695- Secondary thrombocytopenia
Conditions
Interventions
Intervention1: Continuous infusion of Tranexamic acid: ARM B :
Tranexamic acid 10mg/kg as bolus followed by 1000mg over 8hrs as infusion in 500ml NS till the platelet counts are more than 20000
Contr
Sponsors
CMC Ludhiana
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The randomized groups will be studied for number of bleeding events and the grade of bleeding events according to WHO bleeding criteria.Timepoint: Serial platelet count monitoring will be done at least twice a week and the number of bleeding events will be noted daily until the platelet count increases above 20000 at time points of 2 weeks, 4 weeks, 6 weeks and 8 weeks until the intervention is stopped during the period of hospitalization, whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| No of blood components (packed red cells and Platelet rich concentrate) transfusionsTimepoint: At the time of discharge | — |
Countries
India
Contacts
Public ContactDr Poojitha Byreddy
CMC ludhiana
Outcome results
None listed