Hemostasis
Conditions
Brief summary
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
Interventions
DRUGFibrin Pad
Fibrin Patch is 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).
DEVICESURGICEL™
Absorbable hemostat
Sponsors
OMRIX Biopharmaceuticals
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects \>= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures * Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon * Subjects must be willing to participate in the study, and provide written informed consent
Exclusion criteria
* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure * Subject with TBS within an actively infected field * Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine * Subjects with known intolerance to blood products or to one of the components of the study product * Subjects unwilling to receive blood products * Subjects with immunodeficiency diseases (including known HIV) * Subjects who are known, current alcohol and / or drug abusers * Subjects who have participated in another investigational drug or device research study within 30 days of enrollment * Female subjects who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Hemostatic Success | Intra-operative | Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Failures | Intra-operative | If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure. |
| Incidence of Adverse Events That Are Potentially Related to Bleeding | Intra-operative up to 1 month (+14 days) | The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS). |
| Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | Intra-operative up to 1 month (+14 days) | The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism |
| Proportion of Subjects Achieving Hemostatic Success | 10 minutes | The proportion of subjects achieving hemostatic success at 10 minutes following randomization |
| Incidence of Re-treatment | Intra-operative | The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period. In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment. |
| Incidence of Adverse Events | 30 days (+14 days) | — |
| Incidence of Adverse Events Potentially Related to Transfusion Exposure | Intra-operative up to 1 month (+14 days) | The types of events that were potentially related to transfusion exposure could have include hypocalcemia. |
Countries
United States
Participant flow
Recruitment details
A total of 11 clinical centers in the US partipcated in the trial enrolled 141 subjects. The first subject randomized: March 26, 2008 and the last subject completed: April 24, 2009
Pre-assignment details
The efficacy results are based on the intent-to-treat (ITT) set, which is based on 90 randomized subjects from the two randomized arms - Fibrin Pad Randomized and SURGICEL(TM) Randomized. The Fibrin Pad Non-randomized arm was used for the safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| Fibrin Pad All Fibrin Pad: Fibrin Patch is 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). - Randomized & Non Randomized | 111 |
| SURGICEL™ Randomized SURGICEL™ Absorbable Hemostat | 30 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 1 | 4 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 |
| Overall Study | Scheduling Issue | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Fibrin Pad All | SURGICEL™ Randomized | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 9 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 21 Participants | 84 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 5 Participants | 26 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 90 Participants | 23 Participants | 113 Participants |
| Region of Enrollment United States | 111 participants | 30 participants | 141 participants |
| Sex: Female, Male Female | 42 Participants | 10 Participants | 52 Participants |
| Sex: Female, Male Male | 69 Participants | 20 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 105 / 111 | 27 / 30 |
| serious Total, serious adverse events | 40 / 111 | 15 / 30 |
Outcome results
Primary
Proportion of Subjects Achieving Hemostatic Success
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
Time frame: Intra-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Proportion of Subjects Achieving Hemostatic Success | 98.3 percentage of success |
| SURGICEL | Proportion of Subjects Achieving Hemostatic Success | 53.3 percentage of success |
| Fibrin Pad - Non-Randomized | Proportion of Subjects Achieving Hemostatic Success | 98.0 percentage of success |
Secondary
Incidence of Adverse Events
Time frame: 30 days (+14 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Incidence of Adverse Events | 94.6 % if participants with atleast one AE |
| SURGICEL | Incidence of Adverse Events | 90.0 % if participants with atleast one AE |
Secondary
Incidence of Adverse Events Potentially Related to Transfusion Exposure
The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
Time frame: Intra-operative up to 1 month (+14 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Incidence of Adverse Events Potentially Related to Transfusion Exposure | 0 percentage of particpants |
| SURGICEL | Incidence of Adverse Events Potentially Related to Transfusion Exposure | 0 percentage of particpants |
| Fibrin Pad - Non-Randomized | Incidence of Adverse Events Potentially Related to Transfusion Exposure | 0 percentage of particpants |
Secondary
Incidence of Adverse Events That Are Potentially Related to Bleeding
The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
Time frame: Intra-operative up to 1 month (+14 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Incidence of Adverse Events That Are Potentially Related to Bleeding | 0 percentage of particpants |
| SURGICEL | Incidence of Adverse Events That Are Potentially Related to Bleeding | 10 percentage of particpants |
| Fibrin Pad - Non-Randomized | Incidence of Adverse Events That Are Potentially Related to Bleeding | 0 percentage of particpants |
Secondary
Incidence of Adverse Events That Are Potentially Related to Thrombotic Events
The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
Time frame: Intra-operative up to 1 month (+14 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | 1.7 percentage of participants |
| SURGICEL | Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | 6.7 percentage of participants |
| Fibrin Pad - Non-Randomized | Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | 13.7 percentage of participants |
Secondary
Incidence of Re-treatment
The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period. In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.
Time frame: Intra-operative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibrin Pad - Randomized | Incidence of Re-treatment | No hemostasis at 4-minutes and re-treated | 1 participants |
| Fibrin Pad - Randomized | Incidence of Re-treatment | Total Incidence of Re-treatment | 1 participants |
| Fibrin Pad - Randomized | Incidence of Re-treatment | Achieved hemostasis at 4-mins and re-treated | 0 participants |
| SURGICEL | Incidence of Re-treatment | No hemostasis at 4-minutes and re-treated | 12 participants |
| SURGICEL | Incidence of Re-treatment | Total Incidence of Re-treatment | 14 participants |
| SURGICEL | Incidence of Re-treatment | Achieved hemostasis at 4-mins and re-treated | 2 participants |
| Fibrin Pad - Non-Randomized | Incidence of Re-treatment | Total Incidence of Re-treatment | 1 participants |
| Fibrin Pad - Non-Randomized | Incidence of Re-treatment | Achieved hemostasis at 4-mins and re-treated | 0 participants |
| Fibrin Pad - Non-Randomized | Incidence of Re-treatment | No hemostasis at 4-minutes and re-treated | 1 participants |
Secondary
Incidence of Treatment Failures
If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.
Time frame: Intra-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Incidence of Treatment Failures | 1.7 percentage of treatment failure |
| SURGICEL | Incidence of Treatment Failures | 46.7 percentage of treatment failure |
| Fibrin Pad - Non-Randomized | Incidence of Treatment Failures | 2.0 percentage of treatment failure |
Secondary
Proportion of Subjects Achieving Hemostatic Success
The proportion of subjects achieving hemostatic success at 10 minutes following randomization
Time frame: 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibrin Pad - Randomized | Proportion of Subjects Achieving Hemostatic Success | 98.3 percentage of success |
| SURGICEL | Proportion of Subjects Achieving Hemostatic Success | 73.3 percentage of success |
| Fibrin Pad - Non-Randomized | Proportion of Subjects Achieving Hemostatic Success | 100.0 percentage of success |