Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
NCT ID: NCT03050476
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
1250 participants
INTERVENTIONAL
2017-11-01
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
NCT00903604
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
NCT01144611
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
NCT00628264
Apixaban Pharmacokinetics in Bariatric Patients (APB)
NCT02406885
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
NCT06917859
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RESCAP®
Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours.
RESCAP®
intravenous application before, during, and for 24 or 96 hours after heart surgery
Placebo
Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.
placebo
intravenous application before, during, and for 24 or 96 hours after heart surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RESCAP®
intravenous application before, during, and for 24 or 96 hours after heart surgery
placebo
intravenous application before, during, and for 24 or 96 hours after heart surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned
* Ability to provide informed consent (not incapacitated)
Exclusion Criteria
* Patients with chronic kidney disease defined as estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 \[ CKD stage \> 3 \]
* Patients who are pregnant or lactating
* Concurrent enrollment in another clinical trial
* Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan
* Patients with ongoing infections or current use of steroids
* Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aix Scientifics
INDUSTRY
Alloksys Life Sciences B.V.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ruud Brands, PhD
Role: STUDY_CHAIR
Alloksys Life Sciences BV . President
Dominik Wiedemann, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum St. Pölten, Austria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. Cardiothoracic Surgery , Monash Medical Centre
Clayton, Melbourne, Australia
Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz
Graz, , Austria
MedUniWien / AKH-Wien
Vienna, , Austria
Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, , Belgium
Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
Brussels, , Belgium
Hospital ZOL
Genk, , Belgium
Dept. of Anesthesia and Intensive Care, AZ Maria Middelares
Ghent, , Belgium
Jessa Ziekenhuis,Campus Virga Jesse
Hasselt, , Belgium
German Heart Centre Munich, Dept.Cardio-Vascular Surgery
Munich, Bavaria, Germany
Klinik für Herzchirurgie, Universitätsklinik
Leipzig, , Germany
U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Policlinico Gemelli, Institute Cardiology
Roma, , Italy
Institut Jantung Negara (IJN , Natl. Heart Inst.)
Kuala Lumpur, , Malaysia
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Catharina Ziekenhuis, Cathreine R&D, Heartcentre
Eindhoven, , Netherlands
Hospital de Santa Marta
Lisbon, , Portugal
State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
Kazan', , Russia
Federal State Budgetary Military Educational Institution of the Higher Education
Saint Petersburg, , Russia
Almazov Heart Center
Saint Petersburg, , Russia
National University Hospital (NUH),
Singapore, , Singapore
Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NUH-ALS-2015-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.