Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330433

Enrollment

Registered

2011-04-07

Start date

2011-08-31

Completion date

2015-08-31

Last updated

2016-12-15

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

Conditions

Congenital Heart Defect, Hemorrhage, Surgery-Induced Tissue Adhesions

Brief summary

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.

Interventions

DEVICECoSeal Surgical Spray Group

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Adhesion Burden	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.
Severity of Adhesions at the Retrosternal Site	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.	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	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	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	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	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.

Secondary

Measure	Time frame	Description
Hospital Stay	Length of stay after second surgery up to 1 month	Number of days post surgery.

Countries

United States

Participant flow

Participants by arm

Arm	Count
No CoSeal Surgical Spray 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.	16
CoSeal Spray Group CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. CoSeal Surgical Spray Group: 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	19
Total	35

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	1	3
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	CoSeal Spray Group	No CoSeal Surgical Spray	Total
Age, Categorical <=18 years	19 Participants	16 Participants	35 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	1 years	1 years	1 years
Gender Female	7 Participants	2 Participants	9 Participants
Gender Male	12 Participants	14 Participants	26 Participants
Region of Enrollment United States	19 participants	16 participants	35 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 16	0 / 19
serious Total, serious adverse events	1 / 16	3 / 19

Outcome results

Primary

Adhesion Burden

Skin to bypass time as an indicator of adhesion burden.

Time frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)

Arm	Measure	Value (MEAN)	Dispersion
No CoSeal Surgical Spray	Adhesion Burden	37.39 minutes	Standard Deviation 10.445
CoSeal Spray Group	Adhesion Burden	23.44 minutes	Standard Deviation 6.366

Primary

Post-operative Bleeding

Post-operative bleeding through surgical site drainage output.

Time frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery

Population: The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.

Arm	Measure	Value (MEAN)	Dispersion
No CoSeal Surgical Spray	Post-operative Bleeding	106.38 cm^3	Standard Deviation 78.539
CoSeal Spray Group	Post-operative Bleeding	108.64 cm^3	Standard Deviation 116.449

Primary

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).