Unique ID issued by UMIN | UMIN000007864 |
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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 |
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
Antithrombin in kidney transplantation
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
Antithrombin in kidney transplantation
Europe |
End-stage renal failure
Nephrology | Surgery in general |
Others
NO
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
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
primary efficacy variable: degree of graft I/R-injury
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
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.
control group: corresponding dose of human albumin
18 | years-old | <= |
Not applicable |
Male and Female
informed consent, age >18 years, undergoing deceased donor kidney transplantation
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)
70
1st name | |
Middle name | |
Last name | Johannes N. Hoffmann, MD |
Ludwig-Maximilians-University Munich, Germany
Campus Grosshadern, Dpt. of surgery
Marchioninistr. 15, 81377 Munich, Germany
498970950
1st name | |
Middle name | |
Last name | Jan M. Fertmann, MD |
Ludwig-Maximilians-University Munich, Germany
Campus Grosshadern, Dpt. of surgery
Marchioninistr. 15, 81377 Munich, Germany
498970950
http://www.klinikum.uni-muenchen.de/Chirurgische-Klinik-und-Poliklinik-Grosshadern/de/index.html
jan.fertmann@med.uni-muenchen.de
Ludwig-Maximilians-University Munich, Germany
Study is in part funded by Octapharma (Langenfeld, Germany)
Outside Japan
Germany
none
none
NO
University Hospital of Ludwig-Maximilians-University, Campus Grosshadern, Munich, Germany
2012 | Year | 04 | Month | 30 | Day |
Unpublished
Completed
2001 | Year | 06 | Month | 15 | Day |
2001 | Year | 09 | Month | 01 | Day |
2004 | Year | 04 | Month | 01 | Day |
2005 | Year | 08 | Month | 01 | Day |
2005 | Year | 08 | Month | 01 | Day |
2006 | Year | 02 | Month | 01 | Day |
2012 | Year | 04 | Month | 30 | Day |
2012 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009266
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