Cardiac SurgeryPhase 3COLCHIRCARDNCT02584868

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

A Phase 3 study testing Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution and Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 28 days to 3 years
Conditions the study is for: Cardiac Surgery, Cardiopulmonary Bypass
What is being tested?: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution and Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteBelgium
Study dates: 15 Feb 2013to 21 Nov 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 28 days to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 28 days to 3 years old
Planned cardiac surgery with cardiopulmonary by-pass
signed informed consent

Who cannot join

Moribund patients (ASA 5)
Jehovah Witnesses
Pre-operative coagulation disorders
Pre-operative renal insufficiency
Pre-operative hepatic disorders
Intra-cranial hemorrhage
hypernatremia

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020

Other trials in Belgium

About this study

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

Conditions: Cardiac Surgery, Cardiopulmonary Bypass
Being tested: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solutionDrug
Also called Volulyte
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Hydroxyethyl starch 130/0.4 in 0.9% sodium chlorideDrug
Also called Voluven
Peri-operative fluid replacement therapy (max 40ml/kg/day)

Study groups in NCT02584868
Study group	Role	What they receive
Volulyte	Experimental	Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®) Receives: Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Voluven	Active comparator	Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®) Receives: Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (32)

Intraoperative Blood Loss
peri-operative blood losses in ml/kg at the end of surgery
Measured: End of surgery, an average of 200 minutes
Chest Tube Drainage
Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
Measured: 72H post surgery
Total Blood Loss
Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
Measured: 72H post surgery
Exposure to Any Blood Products
Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Exposure to Red Blood Cell
Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Red Blood Cell Transfused
Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Exposure to Fresh Frozen Plasma
Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Fresh Frozen Plasma Transfused
Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Exposure to Platelets
Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Platelet Transfused
Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
Measured: 72H post surgery
Creatinine
Measured: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
C-Reactive Protein (CRP)
Measured: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
PTT
Measured: End of surgery, an average of 200 minutes
APTT
Measured: End of surgery, an average of 200 minutes
INR
Measured: End of surgery, an average of 200 minutes
Fibrinogen
Measured: End of surgery, an average of 200 minutes
Clotting Time in Seconds
Clotting time on EXTEM ROTEM®
Measured: End of surgery, an average of 200 minutes
Maximal Cloth Firmness
Maximal cloth firmness on EXTEM ROTEM®
Measured: End of surgery, an average of 200 minutes
Creatinine
Measured: Post-operative Day 1
CRP
Measured: Post-operative Day 1
PTT
Measured: Post-operative Day 1
APTT
Measured: Post-operative Day 1
INR
Measured: Post-operative Day 1
Fibrinogen
Measured: Post-operative Day 1
Creatinine
Measured: Post-operative Day 2
CRP
Measured: Post-operative Day 2
PTT
Measured: Post-operative Day 2
APTT
Measured: Post-operative Day 2
INR
Measured: Post-operative Day 2
Fibrinogen
Measured: Post-operative Day 2
Creatinine
Measured: Post-operative Day 3
CRP
Measured: Post-operative Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201321 Nov 2016

First posted23 Oct 2015 (estimated)
Study start15 Feb 2013
Primary completion21 Nov 2016
Study completion21 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02584868
Sponsor's protocol ID: 2011-006034-17
Acronym: COLCHIRCARD
Status last verified: Feb 2017
First submitted: 3 Jul 2013
Last updated: 9 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33966019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
ClinicalTrials.gov ID: NCT02584868
Acronym / sponsor ID: COLCHIRCARD / 2011-006034-17
Conditions: Cardiac Surgery, Cardiopulmonary Bypass
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Queen Fabiola Children's University HospitalUniversity, hospital or other
Study start: 15 Feb 2013 (actual)
Primary completion: 21 Nov 2016 (actual)
Study completion: 21 Nov 2016 (actual)
First posted: 23 Oct 2015 (estimated)
Results: Posted 9 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Volulyte	Experimental	Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solutionInvestigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)
Voluven	Active comparator	Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chlorideControl drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)

Who may qualify

Ages: 28 days to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Age 28 days to 3 years old
Planned cardiac surgery with cardiopulmonary by-pass
signed informed consent

Key exclusion criteria (7 listed)

Moribund patients (ASA 5)
Jehovah Witnesses
Pre-operative coagulation disorders
Pre-operative renal insufficiency
Pre-operative hepatic disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solutionAlso: VolulytePeri-operative fluid replacement therapy (max 40ml/kg/day)	Drug	Volulyte
Hydroxyethyl starch 130/0.4 in 0.9% sodium chlorideAlso: VoluvenPeri-operative fluid replacement therapy (max 40ml/kg/day)	Drug	Voluven

Primary outcome

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

32 secondary outcomes

Intraoperative Blood Loss
Time frame: End of surgery, an average of 200 minutes
Chest Tube Drainage
Time frame: 72H post surgery
Total Blood Loss
Time frame: 72H post surgery
Exposure to Any Blood Products
Time frame: 72H post surgery
Exposure to Red Blood Cell
Time frame: 72H post surgery
Red Blood Cell Transfused
Time frame: 72H post surgery
Exposure to Fresh Frozen Plasma
Time frame: 72H post surgery
Fresh Frozen Plasma Transfused
Time frame: 72H post surgery
Exposure to Platelets
Time frame: 72H post surgery
Platelet Transfused
Time frame: 72H post surgery
Creatinine
Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
C-Reactive Protein (CRP)
Time frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
PTT
Time frame: End of surgery, an average of 200 minutes
APTT
Time frame: End of surgery, an average of 200 minutes
INR
Time frame: End of surgery, an average of 200 minutes
Fibrinogen
Time frame: End of surgery, an average of 200 minutes
Clotting Time in Seconds
Time frame: End of surgery, an average of 200 minutes
Maximal Cloth Firmness
Time frame: End of surgery, an average of 200 minutes
Creatinine
Time frame: Post-operative Day 1
CRP
Time frame: Post-operative Day 1
PTT
Time frame: Post-operative Day 1
APTT
Time frame: Post-operative Day 1
INR
Time frame: Post-operative Day 1
Fibrinogen
Time frame: Post-operative Day 1
Creatinine
Time frame: Post-operative Day 2
CRP
Time frame: Post-operative Day 2
PTT
Time frame: Post-operative Day 2
APTT
Time frame: Post-operative Day 2
INR
Time frame: Post-operative Day 2
Fibrinogen
Time frame: Post-operative Day 2
Creatinine
Time frame: Post-operative Day 3
CRP
Time frame: Post-operative Day 3

Results and safety

Results posted to the registry on 9 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saline Colloid	44	44
Balanced Colloid	44	44

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

Time frame: 72H post surgery. Median (Inter-Quartile Range). Unit: ml/kg

Measure	Saline Colloid n = 44	Balanced Colloid n = 44
Value	19.9 (13.8 to 26.1)	15.9 (9.0 to 25.3)

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: through study completion, an average of 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saline Colloid	1 of 44 (2.3%)	14 of 44 (31.8%)	1 of 44
Balanced Colloid	0 of 44 (0%)	10 of 44 (22.7%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33966019Willems 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.

Related trials for Cardiac Surgery

Active, not recruitingObservational study
Associations of Postoperative Hemoglobin With AKI-AKD Trajectories
Patients Undergoing Valvular Heart Surgery
Not yet recruiting
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Cardiac Surgery
Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Recruiting
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe Van der Linden, MDPhD principal investigator

HUDERF

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calculated Blood Loss at 3rd Post Operative Day (POD) (time frame: 72H post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.