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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007864

Enrollment

Registered

2012-04-30

Start date

2001-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal failure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: informed consent, age >18 years, undergoing deceased donor kidney transplantation

Exclusion criteria

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&#160;S)

Design outcomes

Primary

Measure	Time frame
primary efficacy variable: degree of graft I/R-injury	—

Secondary

Measure	Time frame
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.	—

Countries

Europe

Contacts

Public ContactJan M. Fertmann, MD

Ludwig-Maximilians-University Munich, Germany Campus Grosshadern, Dpt. of surgery

jan.fertmann@med.uni-muenchen.de498970950

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026