UMIN ID: UMIN000019027
Registered date:15/09/2015
Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Massive hemorrhage by trauma, gastrointestinal hemorrhage |
| Date of first enrollment | 2014/01/10 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Term:28 weeks infusion:Red cell concentrated 10units, ordinary blood transfusion concentrated fibrin preparation 3g Term:28 weeks infusion:Red cell concentrated 10units, ordinary blood transfusion |
Outcome(s)
| Primary Outcome | The amount of total blood tranfusion until hemostasis completion |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Pregnant woman 2.Under 20 years old 3.Immunocompromised (state) patients 4.Patients with allegy for blood products 5.Patients who are diagnosed as congenital low fibrinogen blood symptom 6.the patient that informed consent is not provided 7.the patient who is dead during primary care treatment even MTP procedure was exercised or not given the treatment with RCC,FFP and the concentrated fibrin preparation. 8.the patient who cannot perform a blood test after dosage |
Related Information
| Primary Sponsor | Trauma and Acute Critical Care Medical Center,Medical Hospital,Tokyo Medical and Dental Universitiy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Tokyo Medical and Dental University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kiyoshi Murata |
| Address | 1-5-45 Yushima Bunkyo-ku Tokyo Japan 113-8510 |
| Telephone | 03-3813-6111 |
| murata.acc@tmd.ac.jp | |
| Affiliation | Medical Hospital,Tokyo Medical and Dental University Trauma and Acute Critical Care Medical Center |
| scientific contact | |
| Name | Yasuhiro Otomo |
| Address | 1-5-45 Yushima Bunkyo-ku Tokyo Japan |
| Telephone | 03-3813-6111 |
| otomo.accm@tmd.ac.jp | |
| Affiliation | Medical Hospital,Tokyo Medical and Dental University Trauma and Acute Critical Care Medical Center |