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Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02584868
Acronym
COLCHIRCARD
Enrollment
88
Registered
2015-10-23
Start date
2013-02-15
Completion date
2016-11-21
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass

Brief summary

This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Interventions

DRUGHydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

Peri-operative fluid replacement therapy (max 40ml/kg/day)

DRUGHydroxyethyl starch 130/0.4 in 0.9% sodium chloride

Peri-operative fluid replacement therapy (max 40ml/kg/day)

Sponsors

Queen Fabiola Children's University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Days to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Calculated Blood Loss at 3rd Post Operative Day (POD)72H post surgery

Secondary

MeasureTime frameDescription
PTTEnd of surgery, an average of 200 minutes—
Intraoperative Blood LossEnd of surgery, an average of 200 minutesperi-operative blood losses in ml/kg at the end of surgery
Chest Tube Drainage72H post surgeryTotal chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
Total Blood Loss72H post surgeryTotal blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
Exposure to Any Blood Products72H post surgeryTransfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)
Exposure to Red Blood Cell72H post surgeryTransfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)
Red Blood Cell Transfused72H post surgeryRed Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)
Exposure to Fresh Frozen Plasma72H post surgeryTransfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)
Fresh Frozen Plasma Transfused72H post surgeryFresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
C-Reactive Protein (CRP)At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)—
Platelet Transfused72H post surgeryPlatelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
CreatinineAt admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)—
APTTEnd of surgery, an average of 200 minutes—
INREnd of surgery, an average of 200 minutes—
FibrinogenEnd of surgery, an average of 200 minutes—
Clotting Time in SecondsEnd of surgery, an average of 200 minutesClotting time on EXTEM ROTEM®
Maximal Cloth FirmnessEnd of surgery, an average of 200 minutesMaximal cloth firmness on EXTEM ROTEM®
CRPPost-operative Day 1—
Exposure to Platelets72H post surgeryTransfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)

Countries

Belgium

Participant flow

Participants by arm

ArmCount
Saline Colloid
6% Hydroxyethyl starch 130/0.4 in NaCl 0.9% (Voluven®)
44
Balanced Colloid
6% hydroxyethyl starch 130/0.4 in an isotonic solution of electrolytes (Volulyte®)
44
Total88

Baseline characteristics

CharacteristicBalanced ColloidTotalSaline Colloid
Age, Categorical
<=18 years
44 Participants88 Participants44 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous6.9 Months6.6 Months6.3 Months
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
Belgium
44 Participants88 Participants44 Participants
Sex: Female, Male
Female
18 Participants42 Participants24 Participants
Sex: Female, Male
Male
26 Participants46 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 440 / 44
other
Total, other adverse events
14 / 4410 / 44
serious
Total, serious adverse events
1 / 440 / 44

Outcome results

Primary

Calculated Blood Loss at 3rd Post Operative Day (POD)

Time frame: 72H post surgery

ArmMeasureValue (MEDIAN)
Saline ColloidCalculated Blood Loss at 3rd Post Operative Day (POD)19.9 ml/kg
Balanced ColloidCalculated Blood Loss at 3rd Post Operative Day (POD)15.9 ml/kg
Secondary

APTT

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEAN)Dispersion
Saline ColloidAPTT39.4 secondeStandard Deviation 5.8
Balanced ColloidAPTT38.6 secondeStandard Deviation 5
Secondary

APTT

Time frame: Post-operative Day 1

ArmMeasureValue (MEAN)
Saline ColloidAPTT31.2 seconde
Balanced ColloidAPTT34.7 seconde
Secondary

APTT

Time frame: Post-operative Day 2

ArmMeasureValue (MEDIAN)
Saline ColloidAPTT31.5 seconde
Balanced ColloidAPTT33.2 seconde
Secondary

Chest Tube Drainage

Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Time frame: 72H post surgery

ArmMeasureValue (MEAN)
Saline ColloidChest Tube Drainage18.8 ml/kg
Balanced ColloidChest Tube Drainage18.8 ml/kg
Secondary

Clotting Time in Seconds

Clotting time on EXTEM ROTEM®

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEDIAN)
Saline ColloidClotting Time in Seconds90.5 secondes
Balanced ColloidClotting Time in Seconds88.0 secondes
Secondary

C-Reactive Protein (CRP)

Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

ArmMeasureValue (MEDIAN)
Saline ColloidC-Reactive Protein (CRP)5.0 mg/dl
Balanced ColloidC-Reactive Protein (CRP)5.0 mg/dl
Secondary

Creatinine

Time frame: Post-operative Day 3

ArmMeasureValue (MEDIAN)
Saline ColloidCreatinine0.25 mg/dl
Balanced ColloidCreatinine0.24 mg/dl
Secondary

Creatinine

Time frame: Post-operative Day 2

ArmMeasureValue (MEDIAN)
Saline ColloidCreatinine0.29 mg/dl
Balanced ColloidCreatinine0.27 mg/dl
Secondary

Creatinine

Time frame: Post-operative Day 1

ArmMeasureValue (MEDIAN)
Saline ColloidCreatinine0.33 mg/dl
Balanced ColloidCreatinine0.30 mg/dl
Secondary

Creatinine

Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)

ArmMeasureValue (MEDIAN)
Saline ColloidCreatinine0.28 mg/dl
Balanced ColloidCreatinine0.29 mg/dl
Secondary

CRP

Time frame: Post-operative Day 1

ArmMeasureValue (MEDIAN)
Saline ColloidCRP31.3 mg/dl
Balanced ColloidCRP39.5 mg/dl
Secondary

CRP

Time frame: Post-operative Day 2

ArmMeasureValue (MEDIAN)
Saline ColloidCRP41.0 mg/dl
Balanced ColloidCRP43.5 mg/dl
Secondary

CRP

Time frame: Post-operative Day 3

ArmMeasureValue (MEDIAN)
Saline ColloidCRP33.0 mg/dl
Balanced ColloidCRP29.6 mg/dl
Secondary

Exposure to Any Blood Products

Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Saline ColloidExposure to Any Blood Products36 Participants
Balanced ColloidExposure to Any Blood Products30 Participants
Secondary

Exposure to Fresh Frozen Plasma

Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Saline ColloidExposure to Fresh Frozen Plasma4 Participants
Balanced ColloidExposure to Fresh Frozen Plasma4 Participants
Secondary

Exposure to Platelets

Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Saline ColloidExposure to Platelets2 Participants
Balanced ColloidExposure to Platelets0 Participants
Secondary

Exposure to Red Blood Cell

Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Saline ColloidExposure to Red Blood Cell35 Participants
Balanced ColloidExposure to Red Blood Cell30 Participants
Secondary

Fibrinogen

Time frame: Post-operative Day 2

ArmMeasureValue (MEAN)Dispersion
Saline ColloidFibrinogen346.2 mg/dlStandard Deviation 82.2
Balanced ColloidFibrinogen352.6 mg/dlStandard Deviation 90.5
Secondary

Fibrinogen

Time frame: Post-operative Day 1

ArmMeasureValue (MEAN)Dispersion
Saline ColloidFibrinogen345.0 mg/dlStandard Deviation 83
Balanced ColloidFibrinogen365.0 mg/dlStandard Deviation 94
Secondary

Fibrinogen

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEAN)Dispersion
Saline ColloidFibrinogen159.0 mg/dlStandard Deviation 51
Balanced ColloidFibrinogen148.0 mg/dlStandard Deviation 38
Secondary

Fresh Frozen Plasma Transfused

Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (MEDIAN)
Saline ColloidFresh Frozen Plasma Transfused12.6 ml/kg
Balanced ColloidFresh Frozen Plasma Transfused12.2 ml/kg
Secondary

INR

Time frame: Post-operative Day 2

ArmMeasureValue (MEDIAN)
Saline ColloidINR1.1 ratio
Balanced ColloidINR1.1 ratio
Secondary

INR

Time frame: Post-operative Day 1

ArmMeasureValue (MEAN)
Saline ColloidINR1.1 ratio
Balanced ColloidINR1.1 ratio
Secondary

INR

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEDIAN)
Saline ColloidINR1.5 ratio
Balanced ColloidINR1.5 ratio
Secondary

Intraoperative Blood Loss

peri-operative blood losses in ml/kg at the end of surgery

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEDIAN)
Saline ColloidIntraoperative Blood Loss4.7 ml/kg
Balanced ColloidIntraoperative Blood Loss4.8 ml/kg
Secondary

Maximal Cloth Firmness

Maximal cloth firmness on EXTEM ROTEM®

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEDIAN)
Saline ColloidMaximal Cloth Firmness50.0 mm
Balanced ColloidMaximal Cloth Firmness48.0 mm
Secondary

Platelet Transfused

Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

Population: No platelet transfusion performed in subjects enrolled in the balanced colloid group

ArmMeasureValue (MEAN)Dispersion
Saline ColloidPlatelet Transfused13.7 ml/kgStandard Deviation 6.4
Secondary

PTT

Time frame: Post-operative Day 2

ArmMeasureValue (MEDIAN)
Saline ColloidPTT86.0 percent
Balanced ColloidPTT80.5 percent
Secondary

PTT

Time frame: Post-operative Day 1

ArmMeasureValue (MEAN)
Saline ColloidPTT87.5 percent
Balanced ColloidPTT81.0 percent
Secondary

PTT

Time frame: End of surgery, an average of 200 minutes

ArmMeasureValue (MEAN)Dispersion
Saline ColloidPTT52.1 percentStandard Deviation 9.4
Balanced ColloidPTT50.1 percentStandard Deviation 10.4
Secondary

Red Blood Cell Transfused

Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

ArmMeasureValue (MEDIAN)
Saline ColloidRed Blood Cell Transfused21.9 ml/kg
Balanced ColloidRed Blood Cell Transfused26.1 ml/kg
Secondary

Total Blood Loss

Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Time frame: 72H post surgery

ArmMeasureValue (MEAN)
Saline ColloidTotal Blood Loss25.7 ml/kg
Balanced ColloidTotal Blood Loss23.4 ml/kg

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026