Congenital Heart DefectPhase 2NCT01330433

Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

A Phase 2 study testing CoSeal Surgical Spray Group in people with Congenital Heart Defect and Surgery-Induced Tissue Adhesions, run by Loma Linda University 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

Who is it for?: Ages Up to 17 years
Conditions the study is for: Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
What is being tested?: CoSeal Surgical Spray Group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Aug 2015
Phase: Phase 2
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 Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Have an acceptable surrogate capable of giving consent on the subject's behalf.
Pediatric patients ages 0 - 17
Have a cardiac disease which requires staged cardiac surgery and resternotomy
Non-emergent state or emergent state with sufficient time to educate and consent

Who cannot join

An immune system disorder
Unplanned reoperation
Known hypersensitivity to components in CoSeal
Patients undergoing reoperation less than 3 months after the primary surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Medical Center
Loma Linda, California, 92602

Other trials in United States

About this study

Official title: Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.

Conditions: Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
Being tested: CoSeal Surgical Spray Group
Medical subject headings: Heart Defects, Congenital, Tissue Adhesions, Hemorrhage

What participants receive

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

CoSeal Surgical Spray GroupDevice
A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
- Patients weighing < 3kg will receive 1ml of CoSeal
- Patients weighing 3-10kg will receive 1-2ml of CoSeal
- Patients weighing >10kg will receive 2-4ml of CoSeal

Study groups in NCT01330433
Study group	Role	What they receive
No CoSeal Surgical Spray	No intervention	A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
CoSeal Spray Group	Experimental	CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. Receives: Device: CoSeal Surgical Spray Group

What is being measured

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

Severity of Adhesions at the Retrosternal Site
Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Measured: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Arterial Base Site.
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Measured: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Diaphragm Site
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Measured: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Left Lateral Site
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Measured: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of Adhesions at the Right Lateral Site
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Measured: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Post-operative Bleeding
Post-operative bleeding through surgical site drainage output.
Measured: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Adhesion Burden
Skin to bypass time as an indicator of adhesion burden.
Measured: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)

Secondary outcomes (1)

Hospital Stay
Number of days post surgery.
Measured: Length of stay after second surgery up to 1 month

Timeline

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

Aug 2011Aug 2015

First posted7 Apr 2011 (estimated)
Study startAug 2011
Primary completionAug 2015
Study completionAug 2015

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.
Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01330433
Sponsor's protocol ID: 5110074
Status last verified: Oct 2016
First submitted: 31 Mar 2011
Last updated: 15 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Congenital Heart Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery
ClinicalTrials.gov ID: NCT01330433
Acronym / sponsor ID: 5110074
Conditions: Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Collaborators: Baxter Healthcare Corporation
Study start: Aug 2011
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 7 Apr 2011 (estimated)
Results: Posted 25 Aug 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
No CoSeal Surgical Spray	No intervention	–A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
CoSeal Spray Group	Experimental	Device: CoSeal Surgical Spray GroupCoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Have an acceptable surrogate capable of giving consent on the subject's behalf.
Pediatric patients ages 0 - 17
Have a cardiac disease which requires staged cardiac surgery and resternotomy
Non-emergent state or emergent state with sufficient time to educate and consent

Key exclusion criteria (4 listed)

An immune system disorder
Unplanned reoperation
Known hypersensitivity to components in CoSeal
Patients undergoing reoperation less than 3 months after the primary surgery

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
CoSeal Surgical Spray GroupA patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows: * Patients weighing < 3kg will receive 1ml of CoSeal * Patients weighing 3-10kg will receive 1-2ml of CoSeal * Patients weighing >10kg will receive 2-4ml of CoSeal	Device	CoSeal Spray Group

Primary outcome

Severity of Adhesions at the Retrosternal Site
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Arterial Base Site.
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Diaphragm Site
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Left Lateral Site
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Severity of Adhesions at the Right Lateral Site
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
Post-operative Bleeding
Time frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Post-operative bleeding through surgical site drainage output.
Adhesion Burden
Time frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)
Skin to bypass time as an indicator of adhesion burden.

1 secondary outcome

Hospital Stay
Time frame: Length of stay after second surgery up to 1 month

Results and safety

Results posted to the registry on 25 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No CoSeal Surgical Spray	16	14
CoSeal Spray Group	19	16

Primary outcome: Severity of Adhesions at the Retrosternal Site

Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery. Number. Unit: percentage of participants

Measure	No CoSeal Surgical Spray n = 14	CoSeal Spray Group n = 16
no adhesions	0	31.3
filmy and avascular	0	37.5
requiring blunt dissection	0	18.8
requiring sharp dissection	78.6	6.3
requiring extensive sharp dissection	21.4	6.3

Primary outcome: Severity of Adhesions at the Arterial Base Site.

Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery. Number. Unit: percentage of participants

Measure	No CoSeal Surgical Spray n = 14	CoSeal Spray Group n = 16
no adhesions	0	12.5
filmy and avascular	0	43.8
requiring blunt dissection	7.1	25.0
requiring sharp dissection	57.1	18.8
requiring extensive sharp dissection	35.7	0.0

Primary outcome: Severity of Adhesions at the Diaphragm Site

Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery. Number. Unit: percentage of participants

Measure	No CoSeal Surgical Spray n = 14	CoSeal Spray Group n = 16
no adhesions	0	0
filmy and avascular	0	85.7
requiring blunt dissection	0	14.3
requiring sharp dissection	100	0
requiring extensive sharp dissection	0	0

Primary outcome: Severity of Adhesions at the Left Lateral Site

Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery. Number. Unit: percentage of participants

Measure	No CoSeal Surgical Spray n = 14	CoSeal Spray Group n = 16
no adhesions	0	8.3
filmy and avascular	0	50.0
requiring blunt dissection	0	8.3
requiring sharp dissection	87.5	33.3
requiring extensive sharp dissection	12.5	0

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No CoSeal Surgical Spray	1 of 16 (6.3%)	0 of 16 (0%)	Not reported
CoSeal Spray Group	3 of 19 (15.8%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congenital Heart Defect

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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.

Nahidh Hasaniya, MD principal investigator

Loma Linda University Medical Center

Anees Razzouk, MD study chair

Loma Linda University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CoSeal Surgical Spray Group in people with Congenital Heart Defect and Surgery-Induced Tissue Adhesions, run by Loma Linda University 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?

The sponsor lists 4 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 15 Dec 2016. 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 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.

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 25 Aug 2016). 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?

Severity of Adhesions at the Retrosternal Site (time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery). The study lists 7 primary outcomes in all. 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 NCT01330433.

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 15 Dec 2016.