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RECRUITING
NCT03050476
PHASE2/PHASE3

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Sponsor: Alloksys Life Sciences B.V.

View on ClinicalTrials.gov

Summary

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

Official title: Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1250

Start Date

2017-11-01

Completion Date

2026-03-31

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

DRUG

RESCAP®

intravenous application before, during, and for 24 or 96 hours after heart surgery

DRUG

placebo

intravenous application before, during, and for 24 or 96 hours after heart surgery

Locations (21)

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