A systematic review and meta-analysis of recombinant human soluble thrombomodulin for the treatment of DIC associated with hematological malignancies

Int J Hematol. 2024 Apr;119(4):416-425. doi: 10.1007/s12185-023-03704-w. Epub 2024 Jan 25.

Abstract

Background: Recombinant human soluble thrombomodulin (rhTM) is commonly used in Japan to treat disseminated intravascular coagulation (DIC), but its efficacy compared with other anticoagulants is unclear. We conducted a systematic review and meta-analysis to investigate this issue in DIC patients with hematological malignancies.

Methods: We searched PubMed, Cochrane, and Scopus for prospective and retrospective studies evaluating the efficacy and safety of rhTM in DIC patients with hematological malignancies between April 2008 and April 2023. We performed a systematic review and meta-analysis evaluating recovery from DIC, hemorrhagic adverse events (AEs), and overall survival (OS).

Results: We analyzed one prospective (64 patients) and seven retrospective studies (209 patients). Use of rhTM was associated with a higher rate of recovery from DIC (OR: 2.25 [1.09-4.63] and 1.98 [1.12-3.50] in prospective and retrospective studies, respectively; same order below) and fewer hemorrhagic AEs (OR: 0.83 [0.30-2.30] and 0.21 [0.08-0.57]). rhTM did not improve OS (OR: 1.06 [0.42-2.66] and 1.72 [0.87-3.39]), although the incidence of hemorrhagic death was lower in the rhTM group (0 of 94 patients).

Conclusion: Use of rhTM in patients with hematological malignancy-associated DIC is strongly expected to be effective and safe.

Keywords: DIC; Hematological malignancy; Hemorrhagic adverse events; Recombinant human thrombomodulin; Recovery from DIC; Treatment outcome.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Disseminated Intravascular Coagulation* / drug therapy
  • Disseminated Intravascular Coagulation* / etiology
  • Hematologic Neoplasms* / complications
  • Hematologic Neoplasms* / drug therapy
  • Hemorrhage
  • Humans
  • Prospective Studies
  • Recombinant Proteins / adverse effects
  • Retrospective Studies
  • Sepsis* / complications
  • Thrombomodulin / therapeutic use
  • Treatment Outcome

Substances

  • Thrombomodulin
  • Recombinant Proteins