Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial

Author:

Gernsheimer Terry B.12,Brown Siobhan P.3,Triulzi Darrell J.4,Key Nigel S.5ORCID,El Kassar Nahed6,Herren Heather3,Poston Jacqueline N.12ORCID,Boyiadzis Michael7,Reeves Brandi N.5ORCID,Selukar Subodh3ORCID,Pagano Monica B.8,Emerson Scott3,May Susanne3

Affiliation:

1. 1Division of Hematology, University of Washington School of Medicine, Seattle, WA;

2. 2Seattle Cancer Care Alliance, Seattle, WA;

3. 3Department of Biostatistics, University of Washington, Seattle, WA;

4. 4Division of Transfusion Medicine, Department of Pathology, University of Pittsburgh, Pittsburgh, PA;

5. 5Division of Hematology and Blood Research Center, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC;

6. 6Division of Blood Diseases and Resources, National Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda, MD;

7. 7Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA; and

8. 8Department of Pathology and Laboratory Medicine, University of Washington, Seattle, WA

Abstract

Abstract Evidence of the effectiveness of prophylactic use of tranexamic acid (TXA) in thrombocytopenia is lacking. To determine whether TXA safely reduces bleeding incidence in patients undergoing treatment for hematologic malignancies, a randomized, double-blind clinical trial was conducted from June 2016 through June 2020. Of 3120 screened adults, 356 patients were eligible and enrolled, and 337 patients (mean age, 53.9; 141 [41.8%] women), randomized to 1300 mg TXA orally or 1000 mg TXA through IV (n = 168) vs placebo (n = 169) thrice daily for maximum 30 days. Three hundred thirty patients were activated when their platelet counts fell below 30 000 per µL; 279 (83%) had complete outcome ascertainment. World Health Organization (WHO) grade ≥2 bleeding was observed in the 30 days following activation in 50.3% (73/145) and 54.2% (78/144) of patients in the TXA and placebo groups, with an adjusted odds ratio of 0.83 (95% confidence interval [CI], 0.50-1.34; P = .44). There was no statistically significant difference in the mean number of platelet transfusions (mean difference, 0.1; 95% CI, −1.9 to 2.0), mean days alive without grade ≥2 bleeding (mean difference, 0.8; 95% CI, −0.4 to 2.0), thrombotic events (6/163 [3.7%] TXA, 9/163 [5.5%] placebo), or deaths due to serious bleeding. Most common adverse events were: diarrhea (116/164 [70.7%] TXA and 114/163 [69.9%] placebo); febrile neutropenia (111/164 [67.7%] TXA, 105/163 [64.4%] placebo); fatigue (106/164 [64.6%] TXA, 109/163 [66.9%] placebo); and nausea (104/164 [63.4%] TXA, 97/163 [59.5%] placebo). Among patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation, prophylactic treatment with TXA compared with placebo did not significantly reduce the risk of WHO grade ≥2 bleeding.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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