UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007864 |
|---|---|
| Receipt number | R000009266 |
| Scientific Title | Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial |
| Date of disclosure of the study information | 2012/04/30 |
| Last modified on | 2012/04/30 00:01:42 |
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Basic information
Public title
Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial
Acronym
Antithrombin in kidney transplantation
Scientific Title
Evaluation of the effect of single-shot high dosed antithrombin in deceased donor kidney transplantation on ischemia/reperfusion injury and safety in a single center controlled randomized trial
Scientific Title:Acronym
Antithrombin in kidney transplantation
Region
| Europe |
Condition
Condition
End-stage renal failure
Classification by specialty
| Nephrology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hypothesis that intraoperative high-dose AT administration can reduce I/R-injury in clinical deceased-donor kidney transplantation and can be applied safely in the clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
primary efficacy variable: degree of graft I/R-injury
Key secondary outcomes
secondary efficacy variable: transplant kidney function; tertiary efficacy variable:12-month graft/patient survival; safety variables relevant to intraoperative AT usage.: incidence of systemic anaphylaxis, incidence of bleeding events, number of units of packed red blood cells administered up to postoperative day 3, incidence of wound complications, and re-operations.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment group: intraoperative administration via central venous line of a single-dose of 4,000 IU of AT (Atenativ, Octapharma, Langenfeld, Germany) at the beginning of the renal vein anastomosis, AT administration completeted by the time of reperfusion.
Interventions/Control_2
control group: corresponding dose of human albumin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
informed consent, age >18 years, undergoing deceased donor kidney transplantation
Key exclusion criteria
ongoing medication with anticoagulant drugs with the exception of acetylsalicylic acid, positive history of bleeding/procoagulant disorders (hereditary AT-deficiency, factor-V-Leiden mutation, prothrombin mutation, antiphospholipid syndromes, deficiency of protein C or protein S)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Johannes N. Hoffmann, MD |
Organization
Ludwig-Maximilians-University Munich, Germany
Division name
Campus Grosshadern, Dpt. of surgery
Zip code
Address
Marchioninistr. 15, 81377 Munich, Germany
TEL
498970950
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jan M. Fertmann, MD |
Organization
Ludwig-Maximilians-University Munich, Germany
Division name
Campus Grosshadern, Dpt. of surgery
Zip code
Address
Marchioninistr. 15, 81377 Munich, Germany
TEL
498970950
Homepage URL
http://www.klinikum.uni-muenchen.de/Chirurgische-Klinik-und-Poliklinik-Grosshadern/de/index.html
jan.fertmann@med.uni-muenchen.de
Sponsor or person
Institute
Ludwig-Maximilians-University Munich, Germany
Institute
Department
Personal name
Funding Source
Organization
Study is in part funded by Octapharma (Langenfeld, Germany)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Germany
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
University Hospital of Ludwig-Maximilians-University, Campus Grosshadern, Munich, Germany
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2001 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 30 | Day |
Last modified on
| 2012 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009266
