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Congenital Heart DefectsPhase 2/3NCT00226369

Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery

A Phase 2/3 study testing CY-1503 in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.

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

We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects. Read more about this study

Who is it for?
Ages Up to 45 days
Conditions the study is for
Congenital Heart Defects
What is being tested?
CY-1503
How many people
242 participants
Where
1 siteUnited States
Study dates
Dec 1997to Jun 2001
Phase
Phase 2/3
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 45 days
  • All sexes
  • No healthy volunteers
  • Child

Inclusion Criteria:1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients -

Exclusion Criteria:Exclusion criteria included the following: 1) need for urgent cardiac surgery, 2) cardiac arrest ≤ 1 week before surgery, 3) prior procedure with hypothermic CPB, 4) acute or chronic infection, 5) major noncardiac congenital anomalies or chromosomal abnormalities, 6) preoperative arterial pH ≤ 7.0, 7) any significant noncardiac organ dysfunction such as renal failure, respiratory failure, seizures, or necrotizing enterocolitis, and 8) use of another investigational drug.

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Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy/Safety of CY-1503 (Cylexin) in Prevention of Reperfusion Injury in Neonates/Infants Undergoing Hypothermic Cardiopulmonary Bypass

We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects.

Read the detailed description

Ischemia/reperfusion (I/R) injury is an important adverse effect of cardiopulmonary bypass (CPB) in infants undergoing cardiac surgery. We performed a multicenter, randomized, placebo-controlled, double-blinded trial of the leukocyte-endothelial cell adhesion inhibitor Cylexin in young infants to determine if it reduces I/R injury following hypothermic CPB. Entry criteria included age at surgery 1-45 days, birth weight > 2.3 kg, and planned repair or palliation of congenital heart defects with CPB. We excluded patients with specified antecedent events or conditions, including lung or kidney disease, seizures, necrotizing enterocolitis, infection, or other serious noncardiac morbidity. Randomization was stratified by study center and cardiac diagnosis. Cylexin was administered continuously from sternotomy until 24 hours post CPB. Centers followed their usual operative and postoperative care practices. From December 1997-March 1999, we enrolled 230 infants, 155 for 2-ventricle repairs (Group 1: D-TGA=90, VSD=16, TOF/truncus=22, TAPVR=9, VSD with aortic arch obstruction=18) and 75 for stage 1 palliation (Group 2: single ventricle with aortic arch obstruction). Of those enrolled, 117 were assigned to Cylexin (Group 1=80, Group 2=47) and 113 to placebo (Group 1=75, Group 2=38). Pre- and intraoperative variables were comparable between treatment groups. Early (30 day) mortality for Cylexin versus placebo patients in Group 1 was 0% versus 3.8% (p=0.25) and for Group 2 was 10.8% versus 28.9% (p=0.08). In both risk groups, treatment with Cylexin did not significantly improve other early postoperative outcomes or decrease the occurrence of adverse events. Cylexin did not significantly improve early mortality or postoperative recovery in Group 1 patients. Despite a small sample size, early mortality in Group 2 Cylexin-treated patients tended to be lower, suggesting the need for future trials of agents that could reduce I/R injury in high-risk infants.

Being tested
CY-1503
Keywords
Pediatric, Cardiopulmonary bypass, Congenital heart disease, Reperfusion injury
Medical subject headings
Heart Defects, Congenital, Reperfusion Injury

What participants receive

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

  • CY-1503Drug

What is being measured

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

  1. 1) non-operative mortality within 30 days, 2) time from ICU admission to extubation, 3) 48-hour Ccr, 4) time to eligibility for ICU discharge, and 5) total inotrope score

Secondary outcomes (1)

  1. 1) A-a O2 gradient during the first 48 hours 2) total urine output in the first 72 hours, 3) total fluid balance during the first 72 hours, and 4) time to hospital discharge

Timeline

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

  1. First posted27 Sep 2005 (estimated)
  2. Study startDec 1997
  3. Study completionJun 2001

Resources

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 2/3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
242 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226369
Sponsor's protocol ID
X04-01-007R
Status last verified
Sep 2005
First submitted
21 Sep 2005
Last updated
12 Feb 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CY-1503 in people with Congenital Heart Defects, run by Boston Children's Hospital at 1 site in United States.

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

Who may be eligible to take part?

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 12 Feb 2010. 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 United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

1) non-operative mortality within 30 days, 2) time from ICU admission to extubation, 3) 48-hour Ccr, 4) time to eligibility for ICU discharge, and 5) total inotrope score. 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 NCT00226369.

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 12 Feb 2010.

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