Hemorrhage, Hepatic Parenchyma Bleeding, Soft Tissue Bleeding
Conditions
Keywords
Fibrin Sealant, Hemostatics, Coagulants
Brief summary
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.
Detailed description
This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients. At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation. Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to \<18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to \<1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment. Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.
Interventions
BIOLOGICALEVARREST™ Sealant Matrix
EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
DEVICESURGICEL®
SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
* Paediatric subjects aged ≥28 days (≥ 1 month) to \<18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects aged ≥1 years to \<18 years. ii) The next 4 subjects to be enrolled will be subjects aged ≥28 days to \<1 year. * The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study. * Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon; * Ability to firmly press trial treatment at TBS until 4 minutes after randomisation
Exclusion criteria
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products; * Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing; * Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor; * Subjects who are known, current alcohol and/or drug abusers * Subjects admitted for trauma surgery * Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure. * Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected) * TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the EVARREST™ or SURGICEL® to blood flow and pressure during healing and absorption of the product; * TBS with major arterial bleeding requiring suture or mechanical ligation; * Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Time to Haemostasis (TTH) | Up to 1 day (Intraoperative) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed. |
| Absolute Time to Haemostasis (TTH) by Age Group | Up to 1 day (Intraoperative) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With No Re-bleeding at the Target Bleeding Site | Up to 44 days post-surgery on Day 0 | Percentage of participants with no re-bleeding at the TBS were reported. |
| Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Up to 44 days post-surgery on Day 0 | Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Up to 44 days post-surgery on Day 0 | Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Number of Participants Who Required Re-treatment At The Target Bleeding Site | Up to 44 days post-surgery on Day 0 | Number of participants who required re-treatment at the TBS were reported. |
| Number of Participants With Adverse Events | Up to 44 days post-surgery on Day 0 | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 4 minutes post randomization (up to 1 day; intraoperative) | Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. |
| Change From Baseline to Post-surgery in Haematocrit | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | Change from baseline to post-surgery in Haematocrit was reported. |
| Change From Baseline to Post-surgery in Platelet Count | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | Change from baseline to post-surgery in platelet count was reported. |
| Estimated Volume of Blood Loss | Up to 1 day (intraoperative) | Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported. |
| Number of Participants Who Received Blood Transfusions | Up to 44 days post-surgery on Day 0 | Number of participants who received blood transfusions (red blood cells \[RBCs\], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported. |
| Change From Baseline to Post-surgery in Haemoglobin | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | Change from baseline to post-surgery in haemoglobin were reported. |
| Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 10 minutes post randomization (up to 1 day; intraoperative) | Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. |
Countries
Belgium, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVARREST Sealant Matrix Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). | 20 |
| SURGICEL Absorbable Hemostat (Control) Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | SURGICEL Absorbable Hemostat (Control) | Total | EVARREST Sealant Matrix |
|---|---|---|---|
| Age, Continuous | 4.0 years | 3.0 years | 3.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 37 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 35 Participants | 18 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 24 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 18 / 20 | 17 / 20 |
| serious Total, serious adverse events | 4 / 20 | 5 / 20 |
Outcome results
Primary
Absolute Time to Haemostasis (TTH)
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.
Time frame: Up to 1 day (Intraoperative)
Population: The Full Analysis Set (FAS; equivalent to the Intent-to-Treat \[ITT\] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVARREST Sealant Matrix | Absolute Time to Haemostasis (TTH) | 4.0 Minutes |
| SURGICEL Absorbable Hemostat (Control) | Absolute Time to Haemostasis (TTH) | 4.0 Minutes |
Primary
Absolute Time to Haemostasis (TTH) by Age Group
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.
Time frame: Up to 1 day (Intraoperative)
Population: The Full Analysis Set (FAS; equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EVARREST Sealant Matrix | Absolute Time to Haemostasis (TTH) by Age Group | Infants and toddlers (28 days to less than 24 months) | 4.0 Minutes |
| EVARREST Sealant Matrix | Absolute Time to Haemostasis (TTH) by Age Group | Children (2 to 11 years) | 4.0 Minutes |
| EVARREST Sealant Matrix | Absolute Time to Haemostasis (TTH) by Age Group | Adolescent (12 to less than 18 years) | 4.0 Minutes |
| SURGICEL Absorbable Hemostat (Control) | Absolute Time to Haemostasis (TTH) by Age Group | Infants and toddlers (28 days to less than 24 months) | 4.0 Minutes |
| SURGICEL Absorbable Hemostat (Control) | Absolute Time to Haemostasis (TTH) by Age Group | Children (2 to 11 years) | 4.0 Minutes |
| SURGICEL Absorbable Hemostat (Control) | Absolute Time to Haemostasis (TTH) by Age Group | Adolescent (12 to less than 18 years) | 4.0 Minutes |
Secondary
Change From Baseline to Post-surgery in Haematocrit
Change from baseline to post-surgery in Haematocrit was reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVARREST Sealant Matrix | Change From Baseline to Post-surgery in Haematocrit | 0.0 Liter of cells per liter of blood (L/L) |
| SURGICEL Absorbable Hemostat (Control) | Change From Baseline to Post-surgery in Haematocrit | -0.0 Liter of cells per liter of blood (L/L) |
Secondary
Change From Baseline to Post-surgery in Haemoglobin
Change from baseline to post-surgery in haemoglobin were reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVARREST Sealant Matrix | Change From Baseline to Post-surgery in Haemoglobin | 0.0 grams/liter (g/L) |
| SURGICEL Absorbable Hemostat (Control) | Change From Baseline to Post-surgery in Haemoglobin | -10.0 grams/liter (g/L) |
Secondary
Change From Baseline to Post-surgery in Platelet Count
Change from baseline to post-surgery in platelet count was reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Population: The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVARREST Sealant Matrix | Change From Baseline to Post-surgery in Platelet Count | -89.0 10^9 cells per liter |
| SURGICEL Absorbable Hemostat (Control) | Change From Baseline to Post-surgery in Platelet Count | -71.5 10^9 cells per liter |
Secondary
Estimated Volume of Blood Loss
Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.
Time frame: Up to 1 day (intraoperative)
Population: The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| EVARREST Sealant Matrix | Estimated Volume of Blood Loss | 100.0 Milliliter (mL) | Full Range 0 |
| SURGICEL Absorbable Hemostat (Control) | Estimated Volume of Blood Loss | 200.0 Milliliter (mL) | Full Range 15 |
Secondary
Number of Participants Who Received Blood Transfusions
Number of participants who received blood transfusions (red blood cells \[RBCs\], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.
Time frame: Up to 44 days post-surgery on Day 0
Population: The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Packed RBCs (0 Unit) | 3 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Packed RBCs (1 Unit) | 4 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Packed RBCs (2 Units) | 4 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Packed RBCs (3 Units) | 1 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Packed RBCs (6 Units) | 0 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Whole Blood (0 Unit) | 9 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Whole Blood (1 Unit) | 2 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Whole Blood (2 Units) | 1 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (0 Unit) | 10 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (2 Units) | 1 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (5 Units) | 1 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Platelets (0 Units) | 8 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Platelets (1 Unit) | 3 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Platelets (2 Units) | 1 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Platelets (3 Units) | 0 Participants |
| EVARREST Sealant Matrix | Number of Participants Who Received Blood Transfusions | Cryoprecipitates (0 Units) | 12 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Cryoprecipitates (0 Units) | 11 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Packed RBCs (0 Unit) | 2 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (0 Unit) | 11 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Packed RBCs (1 Unit) | 4 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Platelets (1 Unit) | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Packed RBCs (2 Units) | 3 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (2 Units) | 0 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Packed RBCs (3 Units) | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Platelets (3 Units) | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Packed RBCs (6 Units) | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Fresh Frozen Plasma (5 Units) | 0 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Whole Blood (0 Unit) | 9 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Platelets (2 Units) | 0 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Whole Blood (1 Unit) | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Platelets (0 Units) | 9 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Received Blood Transfusions | Whole Blood (2 Units) | 1 Participants |
Secondary
Number of Participants Who Required Re-treatment At The Target Bleeding Site
Number of participants who required re-treatment at the TBS were reported.
Time frame: Up to 44 days post-surgery on Day 0
Population: The safety analysis set consists of all participants who received treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Sealant Matrix | Number of Participants Who Required Re-treatment At The Target Bleeding Site | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants Who Required Re-treatment At The Target Bleeding Site | 5 Participants |
Secondary
Number of Participants With Adverse Events
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Population: The safety analysis set consists of all participants who received treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Sealant Matrix | Number of Participants With Adverse Events | 18 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants With Adverse Events | 18 Participants |
Secondary
Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS
Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Population: The safety analysis set consists of all participants who received treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Sealant Matrix | Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | 1 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | 3 Participants |
Secondary
Number of Participants With AEs That Were Potentially Related To Thrombotic Events
Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Population: The safety analysis set consists of all participants who received treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Sealant Matrix | Number of Participants With AEs That Were Potentially Related To Thrombotic Events | 0 Participants |
| SURGICEL Absorbable Hemostat (Control) | Number of Participants With AEs That Were Potentially Related To Thrombotic Events | 0 Participants |
Secondary
Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Time frame: 10 minutes post randomization (up to 1 day; intraoperative)
Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Sealant Matrix | Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 95.0 Percentage of Participants |
| SURGICEL Absorbable Hemostat (Control) | Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 90.0 Percentage of Participants |
Secondary
Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Time frame: 4 minutes post randomization (up to 1 day; intraoperative)
Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Sealant Matrix | Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 80.0 Percentage of Participants |
| SURGICEL Absorbable Hemostat (Control) | Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 60.0 Percentage of Participants |
Secondary
Percentage of Participants With No Re-bleeding at the Target Bleeding Site
Percentage of participants with no re-bleeding at the TBS were reported.
Time frame: Up to 44 days post-surgery on Day 0
Population: The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Sealant Matrix | Percentage of Participants With No Re-bleeding at the Target Bleeding Site | 95.0 Percentage of Participants |
| SURGICEL Absorbable Hemostat (Control) | Percentage of Participants With No Re-bleeding at the Target Bleeding Site | 85.0 Percentage of Participants |