Soft Tissue Surgical BleedingPhase 3NCT01731938
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
A Phase 3 study testing Fibrin Sealant (FS) Grifols and Surgicel® in people with Soft Tissue Surgical Bleeding, run by Grifols Biologicals, LLC at 25 sites in 3 countries.
Trial summary
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Surgical Bleeding
- What is being tested?
- Fibrin Sealant (FS) Grifols and Surgicel®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Nov 2012to Jun 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving soft (non-parenchymous) tissue.
- Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
- A target bleeding site can be identified.
- Target bleeding site has moderate bleeding according to the Investigator's judgment.
Who cannot join
- Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
- Infection in the anatomic surgical area.
- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Previous known sensitivity to any FS Grifols component or any Surgicel® component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- Receiving an organ transplant during the same surgical procedure.
Show all 11Show fewer
- Undergone a therapeutic surgical procedure within 30 days from the screening visit.
- A target bleeding site cannot be identified.
- The target bleeding site has a mild or severe bleeding.
- Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- Application of any topical haemostatic material on the cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States17 sites
327
Albany, New York, 12208
321
Boynton Beach, Florida, 33472
404
Bridgeport, Connecticut, 06606
325
Charleston, South Carolina, 29425
331
Chattanooga, Tennessee, 37403
407
Florence, Alabama, 35630
402
Houston, Texas, 77024
316
Houston, Texas, 77030
314
Memphis, Tennessee, 38613
305
New York, New York, 10016
320, 322, 323
Pasadena, California, 91105
307
Pittsburgh, Pennsylvania, 15224
332
Poughkeepsie, New York, 12601
312
Rochester, Minnesota, 55905
300
St Louis, Missouri, 63110
405
Tacoma, Washington, 98431
304
Winston-Salem, North Carolina, 27157
Hungary5 sites
702
Budapest, 1082
701
Debrecen, 4031
700
Debrecen, 4032
703
Debrecen, 4032
704
Győr, 9023
Serbia3 sites
720, 722, 726, 723
Belgrade, 11000
725
Niš, 18000
721, 724
Novi Sad, 21000
About this study
Official title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.
- Conditions
- Soft Tissue Surgical Bleeding
- Being tested
- Fibrin Sealant (FS) Grifols, Surgicel®
- Keywords
- Fibrin Sealant, Soft tissue open surgery, Oxidized cellulose pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant (FS) GrifolsBiological
Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).
Surgicel®Device
Also called Oxidized regenerated cellulose hemostat
Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Sealant (FS) Grifols | Experimental | Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total). Receives: Biological: Fibrin Sealant (FS) Grifols |
| Surgicel® | Active comparator | Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Receives: Device: Surgicel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Measured: From start of treatment until 4 minutes after treatment start
Secondary outcomes (3)
Time to Hemostasis (TTH)
TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.
Measured: From start of treatment to the end of the 10-minute observational period
Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.
Measured: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
Treatments Failures
The following were considered treatment failures:
Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure.
Measured: From start of treatment to time of completion of surgical closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue Surgical BleedingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Biologicals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731938
- Sponsor's protocol ID
- IG1103
- Status last verified
- Jan 2017
- First submitted
- 19 Nov 2012
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
- ClinicalTrials.gov ID
- NCT01731938
- Acronym / sponsor ID
- IG1103
- Conditions
- Soft Tissue Surgical Bleeding
- Keywords
- Fibrin Sealant, Soft tissue open surgery, Oxidized cellulose pads
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Grifols Biologicals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealant (FS) Grifols | Experimental | Biological: Fibrin Sealant (FS) GrifolsFibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total). |
| Surgicel® | Active comparator | Device: Surgicel®Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving soft (non-parenchymous) tissue.
- Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
- A target bleeding site can be identified.
- Target bleeding site has moderate bleeding according to the Investigator's judgment.
Key exclusion criteria (11 listed)
- Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
- Infection in the anatomic surgical area.
- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Previous known sensitivity to any FS Grifols component or any Surgicel® component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
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 (FS) GrifolsFibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits). | Biological | Fibrin Sealant (FS) Grifols |
| Surgicel®Also: Oxidized regenerated cellulose hemostatUp to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice. | Device | Surgicel® |
Primary outcome
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
Time frame: From start of treatment until 4 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
3 secondary outcomes
Time to Hemostasis (TTH)
Time frame: From start of treatment to the end of the 10-minute observational period
Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.
Time frame: From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment
Treatments Failures
Time frame: From start of treatment to time of completion of surgical closure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant (FS) Grifols and Surgicel® in people with Soft Tissue Surgical Bleeding, run by Grifols Biologicals, LLC at 25 sites in 3 countries.
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 5 inclusion and 11 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Hungary, Serbia. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (time frame: From start of treatment until 4 minutes after treatment start). 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 23 Feb 2017.