Shpilberg, O., Blumenthal, R., Sofer, O., Katz, Y., Chetrit, A., Ramot, B., . . . Ben-Bassat, I. (1995). A controlled trial of tranexamic acid therapy for the reduction of bleeding during treatment of acute myeloid leukemia. Leukemia & lymphoma, 19, 141–144.
 

• Tranexamic acid (TA) dose of 1 g every six hours
• Patients receiving induction were given continuous cytarabine 100 mg/m²/day for seven days with daunorubicin 45 mg/m²/day for three days. If remission failed, they were treated with a second cycle of the same. After remission, they received consolidation of cytarabine 3 g/m² twice daily for six days. Patients aged 51–65 years received consolidation of cytarabine 2 g/m².
• Patients aged 66–75 years received induction of daunorubicin 30 mg/m² and consolidation of cytarabine 500 mg/m².
• Platelet count equation = x10⁹/L
• Severity of bleeding was scored on a scale of 0–3 (0 = no bleeding; 1 = few minor mucosal or cutaneous bleeds; 2 = extreme mucosal or cutaneous bleeds; 3 = major bleeding episodes, including gastrointestinal bleed, hematuria, hemoptysis, retinal, or central nervous system bleed irrespective of transfusions required).
• Patients were examined daily.
   

• N = 38
• AGE = 19–71 years
• KEY DISEASE CHARACTERISTICS: Patients with acute myeloid leukemia (AML) during induction (16 in TA group, 22 in placebo group) or consolidation (10 in TA group, 8 in placebo)
• OTHER KEY SAMPLE CHARACTERISTICS: Patients started with a platelet count of less than 20 or a falling trend and less than 50. Treatment was continued until platelet count was greater than 20 on at least two consecutive counts. Patients were excluded if they had a recent thromboembolic event, evidence or suspicion of thromboembolism, or lab signs of disseminated intravascular coagulation. Pooled platelets were given irrespective of count but only when clinically significant bleeding occurred. Packed red blood cells (RBCs) were transfused to maintain greater than 9 g/dL.

• LOCATION: Israel, 1990–1992

• Randomized, placebo-controlled, double-blind study

• Efficacy of TA to reduce bleeding and platelet transfusions during treatment of AML

During induction, there was no difference between the study and control regarding period of thrombocytopenia less than 20, number of bleeding episodes, number of platelet or RBC transfusions, or score of bleeding events. During consolidation, there was significantly less bleeding in the TA group, resulting in less platelets (3.7 +/- 4.1 [p < .05]); there was no significant difference in the number of RBCs transfused. No thromboembolic event or fatal bleeds occurred in either group.
 

• Small size
• Author’s discussion: Lack of benefit during induction could be because of more complex coagulopathy in induction phase, possibly because of more blasts present at induction versus consolidation.
• The TA dose was too low with sub-therapeutic drug levels during induction.