End Stage Renal DiseaseKTXNCT02568696
Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
An observational study of End Stage Renal Disease and Reperfusion Injury, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to investigate local activation of the coagulation system in the kidney graft during organ preservation and during early reperfusion in adult kidney transplantation. Generation of thrombin and fibrin as well as activation and inhibition of fibrinolysis will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Reperfusion Injury, Delayed Graft Function
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In Finland all adult kidney transplantation surgeries are performed at investigators institution. Study population consists of all adult patients fulfilling inclusion criteria admitted to the hospital for cadaveric renal transplantation.
Who may be able to join
- adult person (over 18 years old)
- cadaveric transplantation
- conventional standard immunosuppression plan (methylprednisolone, cyclosporin A, mycophenolate mofetil)
Who cannot join
- previous kidney transplant
- other than local standard immunosuppression
- panel reactive antibodies (PRA) >30%
- warfarin therapy
- dual anti-platelet therapy
- use of low molecular weight heparins (LMWH) or fondaparinux during last two weeks before surgery for other indication than hemodialysis
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University and Helsinki University Hospital
Helsinki, 00029
About this study
Official title: Activation of Coagulation Pathways in Clinical Renal Allotransplantation and Delayed Graft Function and Acute Rejection of the Graft
The purpose of this study is to investigate local activation of the coagulation system in the kidney graft during organ preservation and during early reperfusion in adult kidney transplantation. Generation of thrombin and fibrin as well as activation and inhibition of fibrinolysis will be investigated. Influence of these events on delayed graft function (DGF) and acute cell-mediated rejection will be evaluated.
Read the detailed description
Background
In clinical kidney transplantation organ retrieval, cold-preservation of the graft as well as restoration of the blood flow to the transplant cause tissue damage (ischemia/reperfusion injury). Clinically these events can manifest themselves as delayed graft function (DGF), which is usually defined as the need for dialysis during first week after transplantation. DGF increases the risk of developing chronic rejection and subsequently loss of the transplant.
Ischaemia/reperfusion injury is biologically characterized by local profound inflammatory response, activation of the coagulation system and endothelial dysfunction in the transplanted organ. After reperfusion activated neutrophils cause tissue damage in the graft by production of reactive oxygen species (ROS) and release of proteolytic enzymes, which lead to plugging of the capillaries by accumulation of thrombocytes and fibrin. Blood flow is further diminished by increased blood viscosity and local vasoconstriction and swelling of the endothelial cells. Disorders of the microcirculation lead to "no-reflow" phenomenon whereby locally tissues remain ischemic, despite of good blood flow in the organ artery and vein.
Coagulation is activated in the renal transplant during reperfusion, when circulating factor VIIa (FVIIa) comes into contact with the tissue factor (TF), which is expressed on the endothelium due to ischaemia. FVII-TF complex activates factor X (FX) and activated FX (FXa) cleaves thrombin (FII) from prothrombin. Thrombin activates thrombocytes, cleaves fibrin from fibrinogen and activates factor XIII( FXIII), which stabilizes fibrin clot. Fibrin has been demonstrated to accumulate in the kidney graft during reperfusion. Fibrin accumulation is aggravated by inhibition of fibrinolysis due to reperfusion.
Furthermore, the investigators conducting this current research project, have previously gained indirect evidence in a small cohort study, that accumulation of fibrin occurs even before reperfusion, during donor care and organ retrieval. Most importantly, specifically this pre-reperfusion fibrin deposition was related to DGF.
Patients and sample size
There were several limitations in investigators previous study concerning intra-graft coagulation events in DGF. It was conducted as a part of a larger trial in renal transplantation and included only 30 patients in two study arms with different immunosuppressant regimens (peri-operative basiliximab and conventional triple therapy). Therefore, a new study, with larger sample size and standardized immunosuppression is warranted.
Therefore, in this current prospective observational study surgical technique, anaesthesia and hemodynamic management, immunosuppressive medications are strictly standardized. Sample size is increased to 100. The investigators prospectively screen all adult patients receiving their first kidney transplant from cadaveric donor. Only patients scheduled to receive local standard triple immunosuppressant therapy with cyclosporine A, mycophenolate mofetil and methylprednisolone are included.
Blood samples and prospective data collection
Blood samples for assessment of intra-graft coagulation events (generation of thrombin and fibrin, activation and inhibition of fibrinolysis) are drawn peri-operatively. Predefined clinical and demographical data are collected preoperatively and prospectively during 3 months after kidney transplantation to assess the influence of these coagulation events on delayed graft function according to Halloran criteria (8) (primary outcome) and acute cell mediated graft rejection (primary outcome).
- Conditions
- End Stage Renal Disease, Reperfusion Injury, Delayed Graft Function, Kidney Transplantation
- Keywords
- kidney transplantation, renal transplantation, fibrinolysis, cell mediated rejection, coagulation, delayed graft function, Halloran criteria, graft rejection, thrombin generation, fibrin generation
- Medical subject headings
- Kidney Failure, Chronic, Reperfusion Injury, Delayed Graft Function, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-renal difference/ratio of plasma concentrations of coagulation measurements
Trans-transplant difference/ratio is determined in order to correlate intra-graft coagulation events to the incidences of other primary outcomes.
Measured: Two minutes after reperfusion of the kidney transplant
Delayed Graft Function
Delayed graft function is assessed by Halloran criteria: oliguria < 1000ml/24h for more than 2 days after transplantation or plasma creatinine >500 micromol/l during the first week after transplantation or more than one dialysis during the first week after transplantation (Halloran et al, Transplantation 1988;46:223-8.)
Measured: During 1 week after kidney transplantation
Acute cell mediated graft rejection
Measured: During 3 months after kidney transplantation
Secondary outcomes (16)
Plasma creatinine value (micromol/L)
Measured: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Plasma urea value (mmol/L)
Measured: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Estimated glomerular filtration rate (ml/min/1.73 m2)
Estimated glomerular filtration rate is calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Measured: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Urine output (ml/24h)
Urine output (ml/24h) before the surgery and during the first week after transplantation will be recorded
Measured: Pre-operative urine output (ml/24h) and daily urine output (ml/24h) during the first week after transplantation
Renal artery and renal vein blood flow (ml/min)
Renal artery and renal vein blood flow (ml/min) are measured intra-operatively immediately after blood sample retrieval using a specific probe
Measured: Immediately after blood sample retrieval during reperfusion
Fluid balance during surgery and post-anesthesia care unit stay (ml)
All fluids infused from the start of the kidney transplantation surgery until discharge from the post-anaesthesia care unit (until discharge to the ward) are recorded. All fluids losses (blood loss, urine output) during this period are recorded.
Measured: From the start of the kidney transplantation surgery until the discharge from post-anesthesia care unit (up to 24 hours from the start of the surgery)
Transfusion
All blood products used during this time frame are recorded and reported
Measured: From the start of the kidney transplantation surgery until the discharge from post-anesthesia care unit (up to 24 hours from the start of the surgery)
Prothrombin fragment 1+2 (F1+2)
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess thrombin generation.
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Fibrinopeptide A
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess fibrin generation.
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
D-dimers
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess fibrin degradation
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Tissue type plasminogen activator
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess activation of fibrinolysis.
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Plasminogen activator inhibitor
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess inhibition of fibrinolysis.
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Syndecan-1
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess degradation of endothelial glycocalyx
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Myeloperoxidase and/or lactoferrin
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess activation of neutrophiles
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Interleukin 6, interleukin 8, interleukin 10
Preoperative value and the trans-transplant difference and/or ratio is determined in order to assess activation/inhibition of inflammation
Measured: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Number of hemodialyses and their indication after surgery
All dialysis sessions will be recorded during first post-operative week. Indication for dialysis (oliguria, hyperkalemia, hypervolemia, acidosis) will be recorded during first post-operative week. At 1 and 3 months after surgery only number of dialyses/week will be recorded
Measured: From the start of the surgery until 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startJun 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Arie Passov, Helsinki University Central Hospital
- Investigators
- Eero Pesonen, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568696
- Sponsor's protocol ID
- Dnro/64/13/03/02/2015
- Other IDs
- Dnro/64/13/03/02/2015
- Acronym
- KTX
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
PubMed 22064429Nemeth N, Furka I, Miko I. Hemorheological changes in ischemia-reperfusion: an overview on our experimental surgical data. Clin Hemorheol Microcirc. 2014;57(3):215-25. doi: 10.3233/CH-131648.
PubMed 23340000Sevastos J, Kennedy SE, Davis DR, Sam M, Peake PW, Charlesworth JA, Mackman N, Erlich JH. Tissue factor deficiency and PAR-1 deficiency are protective against renal ischemia reperfusion injury. Blood. 2007 Jan 15;109(2):577-83. doi: 10.1182/blood-2006-03-008870. Epub 2006 Sep 21.
PubMed 16990608Esmon CT. Targeting factor Xa and thrombin: impact on coagulation and beyond. Thromb Haemost. 2014 Apr 1;111(4):625-33. doi: 10.1160/TH13-09-0730. Epub 2013 Dec 12.
PubMed 24336942Sorensen-Zender I, Rong S, Susnik N, Lange J, Gueler F, Degen JL, Melk A, Haller H, Schmitt R. Role of fibrinogen in acute ischemic kidney injury. Am J Physiol Renal Physiol. 2013 Sep 1;305(5):F777-85. doi: 10.1152/ajprenal.00418.2012. Epub 2013 Jun 26.
PubMed 23804451Favreau F, Thuillier R, Cau J, Milin S, Manguy E, Mauco G, Zhu X, Lerman LO, Hauet T. Anti-thrombin therapy during warm ischemia and cold preservation prevents chronic kidney graft fibrosis in a DCD model. Am J Transplant. 2010 Jan;10(1):30-9. doi: 10.1111/j.1600-6143.2009.02924.x. Epub 2009 Dec 2.
PubMed 19958330Turunen AJ, Lindgren L, Salmela KT, Kyllonen LE, Petaja J, Pesonen EJ. Intragraft coagulation events and delayed graft function in clinical renal transplantation. Transplantation. 2008 Mar 15;85(5):693-9. doi: 10.1097/TP.0b013e31816615d8.
PubMed 18337662Halloran PF, Aprile MA, Farewell V, Ludwin D, Smith EK, Tsai SY, Bear RA, Cole EH, Fenton SS, Cattran DC. Early function as the principal correlate of graft survival. A multivariate analysis of 200 cadaveric renal transplants treated with a protocol incorporating antilymphocyte globulin and cyclosporine. Transplantation. 1988 Aug;46(2):223-8.
PubMed 3043779
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Coagulation Pathways in Clinical Renal Allotransplantation and Delayed Graft Function and Acute Rejection of the Graft
- ClinicalTrials.gov ID
- NCT02568696
- Acronym / sponsor ID
- KTX / Dnro/64/13/03/02/2015
- Conditions
- End Stage Renal Disease, Reperfusion Injury, Delayed Graft Function, Kidney Transplantation
- Keywords
- kidney transplantation, renal transplantation, fibrinolysis, cell mediated rejection, coagulation, delayed graft function, Halloran criteria, graft rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Jun 2015
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate local activation of the coagulation system in the kidney graft during organ preservation and during early reperfusion in adult kidney transplantation. Generation of thrombin and fibrin as well as activation and inhibition of fibrinolysis will be investigated. Influence of these events on delayed graft function (DGF) and acute cell-mediated rejection will be evaluated.
Detailed description
Background
In clinical kidney transplantation organ retrieval, cold-preservation of the graft as well as restoration of the blood flow to the transplant cause tissue damage (ischemia/reperfusion injury). Clinically these events can manifest themselves as delayed graft function (DGF), which is usually defined as the need for dialysis during first week after transplantation. DGF increases the risk of developing chronic rejection and subsequently loss of the transplant.
Ischaemia/reperfusion injury is biologically characterized by local profound inflammatory response, activation of the coagulation system and endothelial dysfunction in the transplanted organ. After reperfusion activated neutrophils cause tissue damage in the graft by production of reactive oxygen species (ROS) and release of proteolytic enzymes, which lead to plugging of the capillaries by accumulation of thrombocytes and fibrin. Blood flow is further diminished by increased blood viscosity and local vasoconstriction and swelling of the endothelial cells. Disorders of the microcirculation lead to "no-reflow" phenomenon whereby locally tissues remain ischemic, despite of good blood flow in the organ artery and vein.
Coagulation is activated in the renal transplant during reperfusion, when circulating factor VIIa (FVIIa) comes into contact with the tissue factor (TF), which is expressed on the endothelium due to ischaemia. FVII-TF complex activates factor X (FX) and activated FX (FXa) cleaves thrombin (FII) from prothrombin. Thrombin activates thrombocytes, cleaves fibrin from fibrinogen and activates factor XIII( FXIII), which stabilizes fibrin clot. Fibrin has been demonstrated to accumulate in the kidney graft during reperfusion. Fibrin accumulation is aggravated by inhibition of fibrinolysis due to reperfusion.
Furthermore, the investigators conducting this current research project, have previously gained indirect evidence in a small cohort study, that accumulation of fibrin occurs even before reperfusion, during donor care and organ retrieval. Most importantly, specifically this pre-reperfusion fibrin deposition was related to DGF.
Patients and sample size
There were several limitations in investigators previous study concerning intra-graft coagulation events in DGF. It was conducted as a part of a larger trial in renal transplantation and included only 30 patients in two study arms with different immunosuppressant regimens (peri-operative basiliximab and conventional triple therapy). Therefore, a new study, with larger sample size and standardized immunosuppression is warranted.
Therefore, in this current prospective observational study surgical technique, anaesthesia and hemodynamic management, immunosuppressive medications are strictly standardized. Sample size is increased to 100. The investigators prospectively screen all adult patients receiving their first kidney transplant from cadaveric donor. Only patients scheduled to receive local standard triple immunosuppressant therapy with cyclosporine A, mycophenolate mofetil and methylprednisolone are included.
Blood samples and prospective data collection
Blood samples for assessment of intra-graft coagulation events (generation of thrombin and fibrin, activation and inhibition of fibrinolysis) are drawn peri-operatively. Predefined clinical and demographical data are collected preoperatively and prospectively during 3 months after kidney transplantation to assess the influence of these coagulation events on delayed graft function according to Halloran criteria (8) (primary outcome) and acute cell mediated graft rejection (primary outcome).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In Finland all adult kidney transplantation surgeries are performed at investigators institution. Study population consists of all adult patients fulfilling inclusion criteria admitted to the hospital for cadaveric renal transplantation.
Key inclusion criteria (3 listed)
- adult person (over 18 years old)
- cadaveric transplantation
- conventional standard immunosuppression plan (methylprednisolone, cyclosporin A, mycophenolate mofetil)
Key exclusion criteria (6 listed)
- previous kidney transplant
- other than local standard immunosuppression
- panel reactive antibodies (PRA) >30%
- warfarin therapy
- dual anti-platelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trans-renal difference/ratio of plasma concentrations of coagulation measurements
Time frame: Two minutes after reperfusion of the kidney transplant
Trans-transplant difference/ratio is determined in order to correlate intra-graft coagulation events to the incidences of other primary outcomes.
Delayed Graft Function
Time frame: During 1 week after kidney transplantation
Delayed graft function is assessed by Halloran criteria: oliguria < 1000ml/24h for more than 2 days after transplantation or plasma creatinine >500 micromol/l during the first week after transplantation or more than one dialysis during the first week after transplantation (Halloran et al, Transplantation 1988;46:223-8.)
Acute cell mediated graft rejection
Time frame: During 3 months after kidney transplantation
16 secondary outcomes
Plasma creatinine value (micromol/L)
Time frame: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Plasma urea value (mmol/L)
Time frame: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Estimated glomerular filtration rate (ml/min/1.73 m2)
Time frame: At admission to the hospital, during the first week after transplantation and at 1 and 3 months after renal transplantation
Urine output (ml/24h)
Time frame: Pre-operative urine output (ml/24h) and daily urine output (ml/24h) during the first week after transplantation
Renal artery and renal vein blood flow (ml/min)
Time frame: Immediately after blood sample retrieval during reperfusion
Fluid balance during surgery and post-anesthesia care unit stay (ml)
Time frame: From the start of the kidney transplantation surgery until the discharge from post-anesthesia care unit (up to 24 hours from the start of the surgery)
Transfusion
Time frame: From the start of the kidney transplantation surgery until the discharge from post-anesthesia care unit (up to 24 hours from the start of the surgery)
Prothrombin fragment 1+2 (F1+2)
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Fibrinopeptide A
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
D-dimers
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Tissue type plasminogen activator
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Plasminogen activator inhibitor
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Syndecan-1
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Myeloperoxidase and/or lactoferrin
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Interleukin 6, interleukin 8, interleukin 10
Time frame: Blood samples are taken at two timepoints: 1) immediately before the start of the surgery; 2) 2 minutes after reperfusion of the kidney transplant
Number of hemodialyses and their indication after surgery
Time frame: From the start of the surgery until 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 22064429Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
- Background: PubMed 23340000Nemeth N, Furka I, Miko I. Hemorheological changes in ischemia-reperfusion: an overview on our experimental surgical data. Clin Hemorheol Microcirc. 2014;57(3):215-25. doi: 10.3233/CH-131648.
- Background: PubMed 16990608Sevastos J, Kennedy SE, Davis DR, Sam M, Peake PW, Charlesworth JA, Mackman N, Erlich JH. Tissue factor deficiency and PAR-1 deficiency are protective against renal ischemia reperfusion injury. Blood. 2007 Jan 15;109(2):577-83. doi: 10.1182/blood-2006-03-008870. Epub 2006 Sep 21.
- Background: PubMed 24336942Esmon CT. Targeting factor Xa and thrombin: impact on coagulation and beyond. Thromb Haemost. 2014 Apr 1;111(4):625-33. doi: 10.1160/TH13-09-0730. Epub 2013 Dec 12.
- Background: PubMed 23804451Sorensen-Zender I, Rong S, Susnik N, Lange J, Gueler F, Degen JL, Melk A, Haller H, Schmitt R. Role of fibrinogen in acute ischemic kidney injury. Am J Physiol Renal Physiol. 2013 Sep 1;305(5):F777-85. doi: 10.1152/ajprenal.00418.2012. Epub 2013 Jun 26.
- Background: PubMed 19958330Favreau F, Thuillier R, Cau J, Milin S, Manguy E, Mauco G, Zhu X, Lerman LO, Hauet T. Anti-thrombin therapy during warm ischemia and cold preservation prevents chronic kidney graft fibrosis in a DCD model. Am J Transplant. 2010 Jan;10(1):30-9. doi: 10.1111/j.1600-6143.2009.02924.x. Epub 2009 Dec 2.
- Background: PubMed 18337662Turunen AJ, Lindgren L, Salmela KT, Kyllonen LE, Petaja J, Pesonen EJ. Intragraft coagulation events and delayed graft function in clinical renal transplantation. Transplantation. 2008 Mar 15;85(5):693-9. doi: 10.1097/TP.0b013e31816615d8.
- Background: PubMed 3043779Halloran PF, Aprile MA, Farewell V, Ludwin D, Smith EK, Tsai SY, Bear RA, Cole EH, Fenton SS, Cattran DC. Early function as the principal correlate of graft survival. A multivariate analysis of 200 cadaveric renal transplants treated with a protocol incorporating antilymphocyte globulin and cyclosporine. Transplantation. 1988 Aug;46(2):223-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eero Pesonen, PhD study chair
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Reperfusion Injury, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans-renal difference/ratio of plasma concentrations of coagulation measurements (time frame: Two minutes after reperfusion of the kidney transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568696, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.