EUCTR2016-001313-24-DEActive, not recruitingPhase 1
SUbstition of PERioperative Albumin Deficiency Disorders - SUPERADD
Technische Universität München, Fakultät für Medizin0 sites600 target enrollmentStarted: September 5, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. patients older than 18 years
- •2. patients, who voluntarily signed the consent form of the study
- •3. a. ASA III or IV
- •b. planned high risk surgery: open aortic surgery, open revascularization of lower limbs, esophagectomy, cystectomy, pancreatic surgery, hepatic surgery, thrombectomy/embolectomy, amputation of a limb, replacement of artificial hip or knee joint
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 390
Exclusion Criteria
- •1. emergency surgery
- •2. severe liver cirrhosis (Child Pugh C)
- •3. terminal renal insufficiency needing renal replacement therapy
- •4. patients, who have been randomized in SUPERADD before
- •5. patients having a caregiver in medical affairs
- •6. patients with contraindications for albumin
- •7. patients allergic to albumin or substances in the albumin preparation
- •8. pregnant women
- •9. breastfeeding women
- •10. patient with a BMI > 35 kg/m2
Investigators
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