A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC)

Not Applicable

Recruiting

• Conditions: Chronic Disseminated Intravascular Coagulation(Chronic DIC); DIC; D004211

• Registration Number: JPRN-jRCTs041180072
• Lead Sponsor: akayama Takayuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1) Patients with a diagnosis of DIC on the basis of criteria established by the new criteria for DIC research from the Japanase Society of Hemostasis and Thrombosis (2017 version) .
2) Patients aged 15 years and over at the time of consent acquisition .
3) Informed consents are obtained form patients or legal representatives.
4) Patients with clinical symptons such as thrombocytopenia and/or fibrinogenopenia induced by DIC.

Exclusion Criteria

1 Patients with a history or present illness of severe allergy to a drug
2 Patients with severe renal disorder (< CLcr 30mL/min)
3 Patients whom the study drug might induce to bleed
4 Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety
5 Pregnant women, nursing mothers or possibly pregnant women
6 Patients whom the investigator considers to be unsuitable for participation in the study
7 Patients with severe hepatic disorder (< CLcr 30mL/min)
8 Patients treated with direct oral anticoagulants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of apixaban for patients with chronic disseminated intravascular coagulation.<br>DIC score after administration of apixaban (in a week, three weeks, six weeks, 10 weeks, 18 weeks and 6 months)

Secondary Outcome Measures

Name	Time	Method
Safety of apixaban for patients with chronic disseminated intravascular coagulation.<br>Adverse event<br>1. Symptoms of bleeding or organ<br>2. Outcome of the patients<br>3. The results of coagulations parameters (Fibrinogen, AT, TAT, Soluble fibrin, Plasminogen, alfa-2PI, PIC, FDP, D-dimer): before start of medication, after one week<br>of medication, after three weeks of medication, after six weeks of medication, after ten weeks of<br>medication, after eighteen weeks of medication, and after six months of medication<br>4. Adherence of the medicine