Efficacy of recombinant human soluble thrombomodulin for disseminated intravascular coagulation (DIC) occurred in patients with severe sepsis

Not Applicable

• Conditions: Severe sepsis with disseminated intravascular coagulation (DIC)

• Registration Number: JPRN-UMIN000008339
• Lead Sponsor: The ethics committees of National Center For Global Health and Medicine, Japan

Brief Summary

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 was significantly lower in the rhTM group than in the control group, on days 3 and 5.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2015-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. The patients who have the need for the emergency surgery. 2. The patients and/or their family who refuse the intensive care (intratracheal intubation, mechanical ventilation, administration of catecholamine, etc.). 3. The patients who have intracranial bleeding, pulmonary hemorrhage, gastrointestinal hemorrhage (persistent hematemesis, persistent hemorrhagic stool or persistent bleeding from gastrointestinal ulcer). 4. The patients who have fulminant hepatic failure, decompensated cirrhosis, or other sever hepatic diseases. 5. The patients who have allergies to rhTM 6. The pregnant women, or the patients who have the possibility of pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the survival rate after the 28 hospital days and 3 month.

Secondary Outcome Measures

Name	Time	Method
1. SOFA score, MODS score 2. CRP value, platelet value, FDP value, D-dimer value 3. Duration of administration of catecholamine 4. Total fluid value until stopping administration of catecholamine 5. The volume of blood transfusion until 72 hours and the total volume until the discharge (RBC volume, FFP volume, platelet volume) 6. Duration of mechanical ventilation 7. The survival rate of 72 hours