Data from: Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial

Objective: To determine whether treatment with recombinant human
thrombomodulin (rhTM) increases survival among severe septic patients with
sepsis-induced disseminated intravascular coagulation (DIC) Design:
Single-center, open-label, randomized controlled trial Setting: Single
tertiary hospital Participant: 92 severe septic patients with
sepsis-induced DIC Interventions: Patients with DIC scores ≥4, as defined
by the Japanese Association of Acute Medicine, were diagnosed with DIC.
Randomization was performed by the envelope method. The treatment group
(rhTM group, n = 47) was intravenously treated with rhTM within 24 h of
admission (day 0), and the control group (n = 45) did not receive any
anti-coagulants, except in cases of deep venous thrombosis and pulmonary
embolism. Primary and secondary measurements: Data were collected on days
0 (admission), 1, 2, 3, 5, 7, and 10. The primary outcome was survival at
28 and 90 days. The secondary endpoints comprised changes in DIC scores,
platelet counts, D-dimer, antithrombin III (ATIII), and C-reactive protein
(CRP) levels, and Sequential Organ Failure Assessment (SOFA) scores. All
analyses were conducted on an intent-to-treat basis. Main Results: The
28-day survival rates were 84 and 83% in the control and rhTM groups,
respectively (p = 0.745, log rank test). The 90-day survival rates were
73% and 72% in the control and rhTM groups, respectively (p = 0.94, log
rank test). Meanwhile, the rates of recovery from DIC (<4) were
significantly higher in the rhTM group than in the control group (p =
0.001, log rank test). Relative change from baseline of D-dimer levels
were significantly lower in the rhTM group than in the control group, on
day 3 and 5. Conclusion: rhTM treatment decreased D-dimer levels and
facilitated DIC recovery in severe septic patients with sepsis-induced
DIC. However, the treatment did not improve survival in this cohort.