Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01330433 | Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery | PHASE2 | COMPLETED | 35 | — | — | Aug 1, 2011 | Aug 1, 2015 | Dec 15, 2016 | 1 | United States |
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 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 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 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 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 through surgical site drainage output.
Skin to bypass time as an indicator of adhesion burden.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| CoSeal Surgical Spray Group | DEVICE | 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 |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Longeveron Inc. Class A | LGVN | 1 | PHASE2 | Lomecel-B medicinal signaling cells |
| Abbott Laboratories | ABT | 3 | NA | Undisclosed |
| Edwards Lifesciences Corporation | EW | 3 | — | Undisclosed |