Preventing Systemic Inflammation after Cardiac surgery with Alkaline Phosphatase (APPIRED III)
- Conditions
- systemic inflammation as side-effect of heart-lung machine during cardiac surgeryMedDRA version: 20.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 100000004863Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-002663-33-BE
- Lead Sponsor
- Alloksys Life Sciences BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1250
A potential subject must meet all of the following criteria to participate in the study:
1.> 21 years of age (legal adult in Singapore)
2.Undergoing cardiac surgery with planned cardiopulmonary bypass
3.Additive EuroSCORE II = 3
4.Ability to provide informed consent (not incapacitated)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 625
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 625
Any subjects meeting the following criteria at baseline will be excluded:
1.Already on renal replacement therapy
2.Patients with chronic kidney disease defined as estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m². [CKD stage > 3]
3.Patients who are pregnant
4.Concurrent enrolment in another clinical trial
5.Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian, vegan, or does not consume any bovine meat products (beef)
that is, the patient may not be tolerant for bovine proteins
6. Patients with ongoing infections or current use of steroids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method