Clinical trial NCT02584868: Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 88
Sex: ALL
Minimum age (years): 28
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Calculated Blood Loss at 3rd Post Operative Day (POD)
timeFrame: 72H post surgery
Secondary outcomes:
measure: Intraoperative Blood Loss
timeFrame: End of surgery, an average of 200 minutes
measure: Chest Tube Drainage
timeFrame: 72H post surgery
measure: Total Blood Loss
timeFrame: 72H post surgery
measure: Exposure to Any Blood Products
timeFrame: 72H post surgery
measure: Exposure to Red Blood Cell
timeFrame: 72H post surgery
measure: Red Blood Cell Transfused
timeFrame: 72H post surgery
measure: Exposure to Fresh Frozen Plasma
timeFrame: 72H post surgery
measure: Fresh Frozen Plasma Transfused
timeFrame: 72H post surgery
measure: Exposure to Platelets
timeFrame: 72H post surgery
measure: Platelet Transfused
timeFrame: 72H post surgery
measure: Creatinine
timeFrame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
measure: C-Reactive Protein (CRP)
timeFrame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
measure: PTT
timeFrame: End of surgery, an average of 200 minutes
measure: APTT
timeFrame: End of surgery, an average of 200 minutes
measure: INR
timeFrame: End of surgery, an average of 200 minutes
measure: Fibrinogen
timeFrame: End of surgery, an average of 200 minutes
measure: Clotting Time in Seconds
timeFrame: End of surgery, an average of 200 minutes
measure: Maximal Cloth Firmness
timeFrame: End of surgery, an average of 200 minutes
measure: Creatinine
timeFrame: Post-operative Day 1
measure: CRP
timeFrame: Post-operative Day 1
measure: PTT
timeFrame: Post-operative Day 1
measure: APTT
timeFrame: Post-operative Day 1
measure: INR
timeFrame: Post-operative Day 1
measure: Fibrinogen
timeFrame: Post-operative Day 1
measure: Creatinine
timeFrame: Post-operative Day 2
measure: CRP
timeFrame: Post-operative Day 2
measure: PTT
timeFrame: Post-operative Day 2
measure: APTT
timeFrame: Post-operative Day 2
measure: INR
timeFrame: Post-operative Day 2
measure: Fibrinogen
timeFrame: Post-operative Day 2
measure: Creatinine
timeFrame: Post-operative Day 3
measure: CRP
timeFrame: Post-operative Day 3
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
Study officials:
affiliation: HUDERF
name: Philippe Van der Linden, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willems A, De Groote F, Schmartz D, Fils JF, Van der Linden P. Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial? Eur J Anaesthesiol. 2021 Sep 1;38(9):923-931. doi: 10.1097/EJA.0000000000001526.