Liver Disease
Conditions
Keywords
Hepatic, Topical Hemostat
Brief summary
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
Interventions
DEVICEVeriset Hemostatic Patch
Topical hemostat
DEVICEFibrin Sealant (TachoSil®)
Topical hemostat
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Scheduled for non-emergent, hepatic surgery * Presence of an appropriate target bleeding site (TBS) as defined by the protocol Major
Exclusion criteria
* Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar * In subjects with documented history of cirrhosis, subject has uncorrected platelet count \<60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery * Subject has severe coagulopathy defined as INR \> 2.0 * Subject has Total Bilirubin \>2.5mg/dL * Subject has an active local infection at the Target Bleeding Site * Study procedure involves a liver transplant recipient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Achieve Hemostasis Following Application of Study Treatment. | Intra-operative (day 1) | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application | Intra-operative (day 1) | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. |
| Number of Subjects With Treatment-emergent Adverse Events | Up to 30 days post surgery. | — |
Countries
Austria, Belgium, Germany
Participant flow
Recruitment details
Subjects who were scheduled for non-emergent, open hepatic surgery were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.
Pre-assignment details
Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were randomized. Subjects who did not meet all criteria were considered screen failures and not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Veriset Hemostatic Patch Subject received the topical hemostat Veriset Hemostatic Patch | 32 |
| Fibrin Sealant (TachoSil®) Subject received the topical hemostat TachoSil® | 18 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Veriset Hemostatic Patch | Fibrin Sealant (TachoSil®) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 18 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 14 Participants | 12 Participants |
| Age, Continuous | 62.1 years STANDARD_DEVIATION 13.4 | 62.2 years STANDARD_DEVIATION 14.9 | 62 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Austria | 10 participants | 6 participants | 4 participants |
| Region of Enrollment Belgium | 16 participants | 11 participants | 5 participants |
| Region of Enrollment Germany | 24 participants | 15 participants | 9 participants |
| Sex: Female, Male Female | 30 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 32 | 10 / 17 |
| serious Total, serious adverse events | 10 / 32 | 8 / 17 |
Outcome results
Primary
Median Time to Achieve Hemostasis Following Application of Study Treatment.
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (day 1)
Population: Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Veriset Hemostatic Patch | Median Time to Achieve Hemostasis Following Application of Study Treatment. | 1 Minutes |
| Fibrin Sealant (TachoSil®) | Median Time to Achieve Hemostasis Following Application of Study Treatment. | 3 Minutes |
Comparison: The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.p-value: <0.0001Log Rank
Secondary
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (day 1)
Population: Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Veriset Hemostatic Patch | Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application | 30 Participants |
| Fibrin Sealant (TachoSil®) | Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application | 12 Participants |
Comparison: The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.p-value: 0.033995% CI: [1.9, 47.3]Suissa and Shuster test
Secondary
Number of Subjects With Treatment-emergent Adverse Events
Time frame: Up to 30 days post surgery.
Population: All treated subjects are included in the Safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Veriset Hemostatic Patch | Number of Subjects With Treatment-emergent Adverse Events | 23 Participants |
| Fibrin Sealant (TachoSil®) | Number of Subjects With Treatment-emergent Adverse Events | 14 Participants |
Comparison: The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.p-value: 0.5029Fisher Exact