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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000030888 |
Receipt No. | R000035269 |
Scientific Title | Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database |
Date of disclosure of the study information | 2018/01/24 |
Last modified on | 2018/12/09 |
Basic information | ||
Public title | Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database | |
Acronym | Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database | |
Scientific Title | Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database | |
Scientific Title:Acronym | Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database | |
Region |
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Condition | |||||||||||
Condition | Disseminated Intravascular Coagulation | ||||||||||
Classification by specialty |
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Classification by malignancy | Others | ||||||||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of recombinant thrombomodulin preparation (rTM; Product name: Recomodulin), a treatment of disseminated intravascular coagulation (DIC), on the incidence of bleeding adverse events by comparing the group of patients receiving rTM with the group of patients receiving drugs other than rTM, on the supposition that "treatment with rTM in patients diagnosed with post-operative DIC does not increase the frequency of bleeding adverse events more significantly than other treatments." |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The incidence proportion of bleeding adverse events |
Key secondary outcomes | The incidence proportion of bleeding adverse events in the case where it is added that a blood transfusion or a hemostatic procedure performed after the DIC treatment. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients who are diagnosed with DIC (ICD-10: D65, disseminated intravascular coagulation [defibrination syndrome]) using the international classification of disease (ICD-10)
2. Patients who are identified as inpatients using the outcome information in the hospital admission and discharge data 3. Patients who are identified to have received DIC treatment using the receipt electronic processing codes 4. Patients who are identified to have received medical treatment defined as "Surgery" according to the clinical practice identification name using the receipt electronic processing codes. "Surgery" covers all surgeries including A), B), C) below A) Digestive organ surgery related to the liver, gallbladder, and pancreas B) Other digestive organ surgery(except for the liver, gallbladder, and pancreas) C) Surgery related to the heart/cardiovascular system *Patients will be included in the study even if they have only a short past history (within 30 days from the initial prescription) or no past history prior to the day of initial prescription. |
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Key exclusion criteria | 1. Patients who do not have even 1 record of outcome information or who do not have outcome information in the hospital admission and discharge data at the time of initial diagnosis of DIC
2. Patients aged under 18 years 3. Patients with DIC in the department of gynecology/obstetrics (pregnant or possibly pregnant women to be contraindicated) 4. Patients who died within 2 days after the day of admission 5. Patients who received surgery on a day that is not in the same month as or in the month before the diagnosis of DIC 6. Patients who had not received DIC treatment 7. Patients who had received the initial dose of DIC treatment prior to the day of surgery or more than 1 week after surgery 8. Patients whose blood test data ("peripheral blood general") are not available 9. Patients who had intracranial hemorrhage, pulmonary hemorrhage, or gastrointestinal hemorrhage before DIC treatment (patients to be contraindicated) 10. Patients who had at least 1 dose of rTM, but no initial prescription of rTM on the day of surgery or within 1 week after that |
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Target sample size | 10000 |
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Name of lead principal investigator |
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Organization | Tohoku University Graduate School of Medicine
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Division name | Biostatistics | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN | ||||||
TEL | 022-717-7659 | ||||||
yamaguchi@med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tohoku University Graduate School of Medicine | ||||||
Division name | Biostatistics | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN | ||||||
TEL | 022-717-7659 | ||||||
Homepage URL | |||||||
yamaguchi@med.tohoku.ac.jp |
Sponsor | |
Institute | CAC Croit Corporation |
Institute | |
Department |
Funding Source | |
Organization | Asahi Kasei Pharma Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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Adverse events | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
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Other | |
Other related information | <Observational Study Model>
Prospective cohort study <Groups> 1. the group of patients receiving rTM 2. the group of patients receiving drugs other than rTM |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035269 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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