Phase 3
N=88
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Cardiac Surgery · Cardiopulmonary Bypass
Bottom Line
View on ClinicalTrials.gov: NCT02584868 ↗Enrolled (actual)
88
Serious AEs
1.1%
Results posted
Nov 2020
Primary outcome: Primary: Calculated Blood Loss at 3rd Post Operative Day (POD) — 19.9; 15.9 ml/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (Drug); Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Queen Fabiola Children's University Hospital
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calculated Blood Loss at 3rd Post Operative Day (POD) |
19.9; 15.9 | — |
| SECONDARY Intraoperative Blood Loss |
4.7; 4.8 | — |
| SECONDARY Chest Tube Drainage |
18.8; 18.8 | — |
| SECONDARY Total Blood Loss |
25.7; 23.4 | — |
| SECONDARY Exposure to Any Blood Products |
36; 30 | — |
| SECONDARY Exposure to Red Blood Cell |
35; 30 | — |
| SECONDARY Red Blood Cell Transfused |
21.9; 26.1 | — |
| SECONDARY Exposure to Fresh Frozen Plasma |
4; 4 | — |
| SECONDARY Fresh Frozen Plasma Transfused |
12.6; 12.2 | — |
| SECONDARY Exposure to Platelets |
2; 0 | — |
| SECONDARY Platelet Transfused |
13.7 | — |
| SECONDARY Creatinine |
0.25; 0.24 | — |
| SECONDARY C-Reactive Protein (CRP) |
5.0; 5.0 | — |
| SECONDARY PTT |
86.0; 80.5 | — |
| SECONDARY APTT |
31.5; 33.2 | — |
| SECONDARY INR |
1.1; 1.1 | — |
| SECONDARY Fibrinogen |
346.2; 352.6 | — |
| SECONDARY Clotting Time in Seconds |
90.5; 88.0 | — |
| SECONDARY Maximal Cloth Firmness |
50.0; 48.0 | — |
| SECONDARY Creatinine |
0.25; 0.24 | — |
| SECONDARY CRP |
33.0; 29.6 | — |
| SECONDARY PTT |
86.0; 80.5 | — |
| SECONDARY APTT |
31.5; 33.2 | — |
| SECONDARY INR |
1.1; 1.1 | — |
| SECONDARY Fibrinogen |
346.2; 352.6 | — |
| SECONDARY Creatinine |
0.25; 0.24 | — |
| SECONDARY CRP |
33.0; 29.6 | — |
| SECONDARY PTT |
86.0; 80.5 | — |
| SECONDARY APTT |
31.5; 33.2 | — |
| SECONDARY INR |
1.1; 1.1 | — |
| SECONDARY Fibrinogen |
346.2; 352.6 | — |
| SECONDARY Creatinine |
0.25; 0.24 | — |
| SECONDARY CRP |
33.0; 29.6 | — |
Summary
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
Eligibility Criteria
Inclusion Criteria
- Age 28 days to 3 years old
- Planned cardiac surgery with cardiopulmonary by-pass
- signed informed consent
Exclusion Criteria
- Moribund patients (ASA 5)
- Jehovah Witnesses
- Pre-operative coagulation disorders
- Pre-operative renal insufficiency
- Pre-operative hepatic disorders
- Intra-cranial hemorrhage
- hypernatremia
Data sourced from ClinicalTrials.gov (NCT02584868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.