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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000002898 |
Receipt No. | R000003535 |
Scientific Title | Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design |
Date of disclosure of the study information | 2009/12/15 |
Last modified on | 2010/12/16 |
Basic information | ||
Public title | Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design | |
Acronym | Prospective Validation of Transfusion after Liver Resection | |
Scientific Title | Prospective Validation of Transfusion Criteria after Liver Resection: A Step-Escalation Design | |
Scientific Title:Acronym | Prospective Validation of Transfusion after Liver Resection | |
Region |
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Condition | ||
Condition | the patients who have malignant liver tumor and underwent liver resection in Nihon University School of Medicine | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To reduce the post operative human blood products transfusion, we prospectively clarify the optimal limit for FFP transfusion after liver resection by phase I manner. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | increase of middle grade postoperative complication without human blood products |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
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Randomization | |
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Stratification | |
Dynamic allocation | |
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Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | The incursion criteria of this study were satisfied the following eligibility: histologically confirmed malignancies, age from 20 to 80 years, well-preserved liver function as Child-Pugh classification A, enable to curative hepatic resection and adequate bone-marrow and renal reserve (blood white cell count >3000/L, platelet >50000/L and serum creatinine <1.5mg/dL). | |||
Key exclusion criteria | The exclusion criteria considered preoperative serum albumin is less than 3.0mg/dL, intraoperative blood loss of more than 1000ml and occurrence of unstable cardiovascular, renal conditions or other serious medical illnesses which conditions cannot be rescued without albumin administration. | |||
Target sample size | 150 |
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Name of lead principal investigator |
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Organization | Nihon University School of Medicine | ||||||
Division name | Department of Digestive Surgery | ||||||
Zip code | |||||||
Address | 30-1 Ohyaguchi Kami-mach Itabashi-ku Tokyo Japan | ||||||
TEL | +81-3-3972-8111 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Nihon University School of Medicine | ||||||
Division name | Department of Digestive Surgery | ||||||
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Homepage URL | |||||||
yamazaki-nmed@umin.ac.jp |
Sponsor | |
Institute | Nihon University School of Medicine partment of Digestive Surgery |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | A dose-escalation design which commonly used in phase I study is applied with some modifications. The starting step of serum albumin value is 3.0g/dl (Step 1), which is to be reducing every 0.2g/dL by step: ex. 2.8mg/dL (Step 2), 2.6mg/dL (Step 3). The step can escalated to the next value when the serum albumin could reach to prescribed value in three patients. If the serum albumin value of post operative day (POD) 2 fell below the prescribed value, 100ml of 25% albumin was transfused on POD2 and 3 to each patient. The step was proceeded until the post operative complication (POC) without transfusion was occurred or the serum albumin considered reaching the lowest limit. |
Management information | |||||||
Registered date |
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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=R000003535 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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