International Journal of Hematology

DOI: 10.1007/s12185-017-2190-8 Pages: 606-613

Evaluation of the safety and efficacy of recombinant soluble thrombomodulin for patients with disseminated intravascular coagulation associated with acute leukemia: multicenter prospective study by the Tohoku Hematology Forum

1. National Hospital Organization, Department of Hematology, Sendai Medical Center

2. Akita University Graduate School of Medicine, Department of Hematology, Nephrology, and Rheumatology

3. Yamagata Prefectural Central Hospital, Department of Hematology

4. Iwate Prefectural Central Hospital, Department of Hematology

5. Fukushima Medical University, Department of Hematology

6. Yamagata University Graduate School of Medicine, Department of Hematology and Cell Therapy

7. Iwate Medical University School of Medicine, Department of Hematology/Oncology

8. Tohoku University Graduate School of Medicine, Department of Hematology and Rheumatology

Correspondence to:
Hisayuki Yokoyama
Tel: 81-22-293-1111
Email: yokoyamah@snh.go.jp

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Abstract

It has been suggested that use of recombinant soluble thrombomodulin (rTM) is superior to conventional drugs in treatment of disseminated intravascular coagulation (DIC) complicating acute leukemia. However, its safety and efficacy have not been fully examined in prospective studies. Here, we performed a multicenter prospective study to examine outcomes of rTM treatment for DIC in patients with acute leukemia. Of 33 patients registered in this study, 13 had acute myeloid leukemia (AML), three had acute lymphoblastic leukemia (ALL), and 17 had acute promyelocytic leukemia (APL). The cumulative rates of DIC resolution at day 7 and day 35 were 56 and 81% in AML/ALL and 53 and 77% in APL, respectively. The median time from the initiation of rTM to DIC resolution was 4 days in AML/ALL and 6 days in APL patients. Adverse events related to hemorrhage occurred in two AML/ALL patients (13%) and three APL patients (18%). Of these, one AML/ALL patient died with intracranial hemorrhage, and two APL patients died with intracranial hemorrhage and pulmonary hemorrhage. These results suggest that rTM may improve the survival of acute leukemia patients with DIC by inhibiting early death related to hemorrhagic events, as reported previously.

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