Congenital Heart DefectsNCT01032876
Cerebral Perfusion During Neonatal Cardiac Surgery
A study testing Deep Hypothermic Circulatory Arrest and Antegrade Cerebral Perfusion in people with Congenital Heart Defects and Hypoplastic Left Heart Syndrome, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation
- What is being tested?
- Deep Hypothermic Circulatory Arrest and Antegrade Cerebral Perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
- Infants <4 months old
Who cannot join
- Anticipated arch reconstruction time longer than 60 minutes
- Sedation and intubation especially for the pre-operative MRI-scan of this research project
- Participation in another clinical trial
- Failure of data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.
Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.
- Being tested
- Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Keywords
- Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Hypothermic Circulatory ArrestProcedure or surgery
DHCA will be employed for a maximum of 60 minutes. If more time (>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP).
Antegrade Cerebral PerfusionProcedure or surgery
One cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min.
| Study group | Role | What they receive |
|---|---|---|
| Deep Hypothermic Circulatory Arrest | Experimental | Not described Receives: Procedure: Deep Hypothermic Circulatory Arrest |
| Antegrade Cerebral Perfusion | Experimental | Not described Receives: Procedure: Antegrade Cerebral Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Measured: Approximately 1 week postoperatively
Secondary outcomes (1)
Mortality within 30 days
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Felix Haas, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032876
- Sponsor's protocol ID
- 08-090/K
- Status last verified
- Jun 2012
- First submitted
- 15 Dec 2009
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Algra SO, Jansen NJ, van der Tweel I, Schouten AN, Groenendaal F, Toet M, van Oeveren W, van Haastert IC, Schoof PH, de Vries LS, Haas F. Neurological injury after neonatal cardiac surgery: a randomized, controlled trial of 2 perfusion techniques. Circulation. 2014 Jan 14;129(2):224-33. doi: 10.1161/CIRCULATIONAHA.113.003312. Epub 2013 Oct 20.
PubMed 24141323Algra SO, Groeneveld KM, Schadenberg AW, Haas F, Evens FC, Meerding J, Koenderman L, Jansen NJ, Prakken BJ. Cerebral ischemia initiates an immediate innate immune response in neonates during cardiac surgery. J Neuroinflammation. 2013 Feb 7;10:24. doi: 10.1186/1742-2094-10-24.
PubMed 23390999Algra SO, Schouten AN, van Oeveren W, van der Tweel I, Schoof PH, Jansen NJ, Haas F. Low-flow antegrade cerebral perfusion attenuates early renal and intestinal injury during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1323-8, 1328.e1-2. doi: 10.1016/j.jtcvs.2012.03.008. Epub 2012 Apr 13.
PubMed 22503201
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01032876
- Acronym / sponsor ID
- 08-090/K
- Keywords
- Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.
Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Hypothermic Circulatory Arrest | Experimental | Procedure: Deep Hypothermic Circulatory Arrest |
| Antegrade Cerebral Perfusion | Experimental | Procedure: Antegrade Cerebral Perfusion |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
- Infants <4 months old
Key exclusion criteria (4 listed)
- Anticipated arch reconstruction time longer than 60 minutes
- Sedation and intubation especially for the pre-operative MRI-scan of this research project
- Participation in another clinical trial
- Failure of data collection
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 |
|---|---|---|
| Deep Hypothermic Circulatory ArrestDHCA will be employed for a maximum of 60 minutes. If more time (>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP). | Procedure or surgery | Deep Hypothermic Circulatory Arrest |
| Antegrade Cerebral PerfusionOne cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min. | Procedure or surgery | Antegrade Cerebral Perfusion |
Primary outcome
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Time frame: Approximately 1 week postoperatively
1 secondary outcome
Mortality within 30 days
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Derived from this study: PubMed 24141323Algra SO, Jansen NJ, van der Tweel I, Schouten AN, Groenendaal F, Toet M, van Oeveren W, van Haastert IC, Schoof PH, de Vries LS, Haas F. Neurological injury after neonatal cardiac surgery: a randomized, controlled trial of 2 perfusion techniques. Circulation. 2014 Jan 14;129(2):224-33. doi: 10.1161/CIRCULATIONAHA.113.003312. Epub 2013 Oct 20.
- Derived from this study: PubMed 23390999Algra SO, Groeneveld KM, Schadenberg AW, Haas F, Evens FC, Meerding J, Koenderman L, Jansen NJ, Prakken BJ. Cerebral ischemia initiates an immediate innate immune response in neonates during cardiac surgery. J Neuroinflammation. 2013 Feb 7;10:24. doi: 10.1186/1742-2094-10-24.
- Derived from this study: PubMed 22503201Algra SO, Schouten AN, van Oeveren W, van der Tweel I, Schoof PH, Jansen NJ, Haas F. Low-flow antegrade cerebral perfusion attenuates early renal and intestinal injury during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1323-8, 1328.e1-2. doi: 10.1016/j.jtcvs.2012.03.008. Epub 2012 Apr 13.
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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.
Felix Haas, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Hypothermic Circulatory Arrest and Antegrade Cerebral Perfusion in people with Congenital Heart Defects and Hypoplastic Left Heart Syndrome, run by UMC Utrecht at 1 site in Netherlands.
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 2 inclusion and 4 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 29 Jun 2012. 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). (time frame: Approximately 1 week postoperatively). 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 NCT01032876, which also lists 3 linked publications.
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 29 Jun 2012.