UMIN ID: UMIN000010632
Registered date:01/05/2013
Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | aortic aneurysm |
| Date of first enrollment | 2013/06/15 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | DIC score (at the day-6 after the commence of the treatment) |
|---|---|
| Secondary Outcome | Blood clotting test findings (FDP, Ddimer, TAT, PIC) AT activity CRP |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients showing intracranial, pulmonary or gastrointestinal hemorrhage. 2) Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others 3) Patients with a history of hypersensitivity to rTM. 4) Pregnant women, nursing mothers or possibly pregnant women. |
Related Information
| Primary Sponsor | Yutaka Okita |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Asahi-Kasei Pharma |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomonori Shirasaka |
| Address | Japan |
| Telephone | |
| Affiliation | Kobe University Graduate School of Medicine, Kobe, Japan Department of Surgery, Division of Cardiovascular Surgery |
| scientific contact | |
| Name | Tomonori Shirasaka |
| Address | 7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo Japan |
| Telephone | 078-382-5942 |
| Affiliation | Kobe University Graduate School of Medicine, Kobe, Japan Department of Surgery, Division of Cardiovascular Surgery |