Intermittent Bolus versus Continuous Infusion of Tranexamic Acid in low platelets
- Conditions
- Health Condition 1: D695- Secondary thrombocytopenia
- Registration Number
- CTRI/2020/07/026319
- Lead Sponsor
- CMC Ludhiana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method o of blood components (packed red cells and Platelet rich concentrate) transfusionsTimepoint: At the time of discharge