Trial Outcomes & Findings for Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery (NCT NCT01330433)

NCT ID: NCT01330433

Last Updated: 2016-12-15

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
• Results posted on: 2016-12-15

Participant Flow

Participant milestones

Measure	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.	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
Overall Study STARTED	16	19
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	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.	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
Overall Study Death	1	3
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Baseline characteristics by cohort

Measure	No CoSeal Surgical Spray n=16 Participants 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 n=19 Participants 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	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	1 years n=5 Participants	1 years n=7 Participants	1 years n=5 Participants
Gender Female	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Gender Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Severity of Adhesions at the Retrosternal Site no adhesions	0 percentage of participants	31.3 percentage of participants
Severity of Adhesions at the Retrosternal Site filmy and avascular	0 percentage of participants	37.5 percentage of participants
Severity of Adhesions at the Retrosternal Site requiring blunt dissection	0 percentage of participants	18.8 percentage of participants
Severity of Adhesions at the Retrosternal Site requiring sharp dissection	78.6 percentage of participants	6.3 percentage of participants
Severity of Adhesions at the Retrosternal Site requiring extensive sharp dissection	21.4 percentage of participants	6.3 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Severity of Adhesions at the Arterial Base Site. no adhesions	0 percentage of participants	12.5 percentage of participants
Severity of Adhesions at the Arterial Base Site. filmy and avascular	0 percentage of participants	43.8 percentage of participants
Severity of Adhesions at the Arterial Base Site. requiring blunt dissection	7.1 percentage of participants	25.0 percentage of participants
Severity of Adhesions at the Arterial Base Site. requiring sharp dissection	57.1 percentage of participants	18.8 percentage of participants
Severity of Adhesions at the Arterial Base Site. requiring extensive sharp dissection	35.7 percentage of participants	0.0 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Severity of Adhesions at the Diaphragm Site no adhesions	0 percentage of participants	0 percentage of participants
Severity of Adhesions at the Diaphragm Site filmy and avascular	0 percentage of participants	85.7 percentage of participants
Severity of Adhesions at the Diaphragm Site requiring blunt dissection	0 percentage of participants	14.3 percentage of participants
Severity of Adhesions at the Diaphragm Site requiring sharp dissection	100 percentage of participants	0 percentage of participants
Severity of Adhesions at the Diaphragm Site requiring extensive sharp dissection	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Severity of Adhesions at the Left Lateral Site no adhesions	0 percentage of participants	8.3 percentage of participants
Severity of Adhesions at the Left Lateral Site filmy and avascular	0 percentage of participants	50.0 percentage of participants
Severity of Adhesions at the Left Lateral Site requiring blunt dissection	0 percentage of participants	8.3 percentage of participants
Severity of Adhesions at the Left Lateral Site requiring sharp dissection	87.5 percentage of participants	33.3 percentage of participants
Severity of Adhesions at the Left Lateral Site requiring extensive sharp dissection	12.5 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Severity of Adhesions at the Right Lateral Site no adhesions	0 percentage of participants	6.3 percentage of participants
Severity of Adhesions at the Right Lateral Site filmy and avascular	0 percentage of participants	25.0 percentage of participants
Severity of Adhesions at the Right Lateral Site requiring blunt dissection	7.7 percentage of participants	50.0 percentage of participants
Severity of Adhesions at the Right Lateral Site requiring sharp dissection	53.8 percentage of participants	18.8 percentage of participants
Severity of Adhesions at the Right Lateral Site requiring extensive sharp dissection	38.5 percentage of participants	0.0 percentage of participants

PRIMARY outcome

Timeframe: 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.

Post-operative bleeding through surgical site drainage output.

Outcome measures

Measure	No CoSeal Surgical Spray n=13 Participants 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 n=14 Participants 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
Post-operative Bleeding	106.38 cm^3 Standard Deviation 78.539	108.64 cm^3 Standard Deviation 116.449

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	No CoSeal Surgical Spray n=14 Participants 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 n=16 Participants 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
Adhesion Burden	37.39 minutes Standard Deviation 10.445	23.44 minutes Standard Deviation 6.366

SECONDARY outcome

Timeframe: Length of stay after second surgery up to 1 month

Population: The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.

Number of days post surgery.

Outcome measures

Measure	No CoSeal Surgical Spray n=12 Participants 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 n=14 Participants 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
Hospital Stay	4.75 days Standard Deviation 2.832	6.29 days Standard Deviation 5.269

Adverse Events

No CoSeal Surgical Spray

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

CoSeal Spray Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No CoSeal Surgical Spray n=16 participants at risk 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 n=19 participants at risk 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
Congenital, familial and genetic disorders Cardiac Arrest unrelated to device	6.2% 1/16 • Number of events 1	15.8% 3/19 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Loma Linda University, Dept of Cardiovascular and Thoracic Surgery

Phone: 909-558-4355

Email: vayermiller@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place