Blood Loss, SurgicalPhase 3NCT00307515
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
A Phase 3 study testing Fibrin Sealant 2 (FS2) and Oxidized Regenerated Cellulose (Surgicel) in people with Blood Loss, Surgical, run by Ethicon, Inc. at 16 sites in United States.
Trial summary
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Fibrin Sealant 2 (FS2) and Oxidized Regenerated Cellulose (Surgicel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2006to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
- Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
- Subjects must be willing to participate in the study and provide written informed consent
Who cannot join
- Subjects undergoing emergency surgery
- Parenchymal or anastomotic bleeding sites will not be considered for randomization
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- Subjects with known intolerance to blood products or to one for the components of the study product
- Subjects unwilling to receive blood products
- Subjects with known autoimmune immunodeficiency diseases (including known HIV
Show all 9Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Medical College of Georgia
Augusta, Georgia, 30912
St. Agnes Healthcare, Inc.
Baltimore, Maryland, 21229
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cooper University Hospital
Camden, New Jersey, 08103
The Iowa Clinic
Des Moines, Iowa, 50309
MD Anderson Cancer Center
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Miami Research Associates
Miami, Florida, 33173
Mt. Sinai Hospital
New York, New York, 10029
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15206
Oregon Health and Science University
Portland, Oregon, 97239
GYN Oncology Associates
Syracuse, New York, 13202
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
Read the detailed description
The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
- Conditions
- Blood Loss, Surgical
- Being tested
- Fibrin Sealant 2 (FS2), Oxidized Regenerated Cellulose (Surgicel)
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant 2 (FS2)Drug
Also called CROSSEAL*, EVICEL*, tissue adhesive
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
Oxidized Regenerated Cellulose (Surgicel)Device
Also called Surgicel*
Commercially available Surgicel used within label.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fibrin Sealant 2 (FS2) Receives: Drug: Fibrin Sealant 2 (FS2) |
| 2 | Active comparator | Oxidized Regenerated Cellulose (Surgicel) Receives: Device: Oxidized Regenerated Cellulose (Surgicel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic success within 10 minutes.
Measured: Intraoperative
Secondary outcomes (4)
Absence of bleeding at pre-defined time points within 10 minutes
Measured: Intraoperative
Incidence of treatment failures
Measured: Intraoperative
Incidence of potential bleeding-related complications
Measured: 24 hr prior to discharge, Day 7-14
Adverse events
Measured: Intraoperative, 24 hr prior to discharge, Day 7-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Investigators
- James Hart, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307515
- Sponsor's protocol ID
- 400-05-006
- Status last verified
- Jan 2009
- First submitted
- 23 Mar 2006
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00307515
- Acronym / sponsor ID
- 400-05-006
- Conditions
- Blood Loss, Surgical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Feb 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
Detailed description
The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fibrin Sealant 2 (FS2)Fibrin Sealant 2 (FS2) |
| 2 | Active comparator | Device: Oxidized Regenerated Cellulose (Surgicel)Oxidized Regenerated Cellulose (Surgicel) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
- Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
- Subjects must be willing to participate in the study and provide written informed consent
Key exclusion criteria (9 listed)
- Subjects undergoing emergency surgery
- Parenchymal or anastomotic bleeding sites will not be considered for randomization
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- Subjects with known intolerance to blood products or to one for the components of the study product
- Subjects unwilling to receive blood products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant 2 (FS2)Also: CROSSEAL*, EVICEL*, tissue adhesiveFS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL | Drug | 1 |
| Oxidized Regenerated Cellulose (Surgicel)Also: Surgicel*Commercially available Surgicel used within label. | Device | 2 |
Primary outcome
Hemostatic success within 10 minutes.
Time frame: Intraoperative
4 secondary outcomes
Absence of bleeding at pre-defined time points within 10 minutes
Time frame: Intraoperative
Incidence of treatment failures
Time frame: Intraoperative
Incidence of potential bleeding-related complications
Time frame: 24 hr prior to discharge, Day 7-14
Adverse events
Time frame: Intraoperative, 24 hr prior to discharge, Day 7-14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
Related trials for Blood Loss, Surgical
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hart, MD study director
Ethicon, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant 2 (FS2) and Oxidized Regenerated Cellulose (Surgicel) in people with Blood Loss, Surgical, run by Ethicon, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic success within 10 minutes. (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2009.