Parenchymous Tissue Surgical BleedingPhase 3NCT01754480
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
A Phase 3 study testing Fibrin Sealant Grifols and Surgicel® in people with Parenchymous Tissue Surgical Bleeding, run by Instituto Grifols, S.A. at 33 sites in 4 countries.
Trial summary
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenchymous Tissue Surgical Bleeding
- What is being tested?
- Fibrin Sealant 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
- 325 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Mar 2013to Dec 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), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
- A target bleeding site can be identified.
- Target bleeding site is identified on the cut raw liver surface (resection area).
- Target bleeding site has moderate bleeding according to the Investigator's judgment.
Who cannot join
- Require hepatic resection 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 Fibrin Sealant 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 resection surface of the liver prior to application of study treatment.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States26 sites
200
Albany, New York, 12208
223
Augusta, Georgia, 30912
229
Bethesda, Maryland, 20889
205
Charleston, South Carolina, 29425
230
Charlotte, North Carolina, 28204
226
Charlottesville, Virginia, 22908
228
Chicago, Illinois, 60611
233
Cincinnati, Ohio, 45219
227
Goshen, Indiana, 46526
400
Hershey, Pennsylvania, 17033
216, 219
Houston, Texas, 77030
231
Las Vegas, Nevada, 89102
224
Loma Linda, California, 92354
214
Los Angeles, California, 90033
207
Louisville, Kentucky, 40202
202
Madison, Wisconsin, 53792
217
Memphis, Tennessee, 38104
206
Nashville, Tennessee, 37232-7610
213
New Haven, Connecticut, 06520
220
New Orleans, Louisiana, 70112
211
New York, New York, 10029
212
New York, New York, 10032
218
Philadelphia, Pennsylvania, 19102
204
Philadelphia, Pennsylvania, 19107
232
Salt Lake City, Utah, 84132
201
St Louis, Missouri, 63110
Serbia3 sites
621, 622, 623
Belgrade, 11000
620, 625
Niš, 18000
624
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 Parenchymous Tissue Open Surgeries
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant 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 Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
- Conditions
- Parenchymous Tissue Surgical Bleeding
- Being tested
- Fibrin Sealant Grifols, Surgicel®
- Keywords
- Fibrin Sealant, Parenchymous tissue open surgery, Hepatic Resection, Oxidized cellulose pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant GrifolsBiological
Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
Surgicel®Device
Also called Fibrillar absorbable hemostat, 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 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 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.
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Subjects achieving hemostasis at the target bleeding site by 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 (4)
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start
Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Measured: From start of treatment until 3 minutes after treatment start
Time to Hemostasis
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
Measured: From start of treatment until 10 minutes after treatment start
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
- At 2 minutes following start of study treatment
- At 5 minutes following start of study treatment
- At 7 minutes following start of study treatment
- At 10 minutes following start of study treatment
Measured: From start of treatment until 10 minutes after treatment start
Prevalence of Treatment Failures
Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.
Measured: From start of treatment until 10 minutes after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 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 Parenchymous 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
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754480
- Sponsor's protocol ID
- IG1102
- Status last verified
- Dec 2016
- First submitted
- 18 Dec 2012
- Last updated
- 8 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 8 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 Parenchymous Tissue Open Surgeries
- ClinicalTrials.gov ID
- NCT01754480
- Acronym / sponsor ID
- IG1102
- Conditions
- Parenchymous Tissue Surgical Bleeding
- Keywords
- Fibrin Sealant, Parenchymous tissue open surgery, Hepatic Resection, Oxidized cellulose pads
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 8 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 Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant 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 Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealant Grifols | Experimental | Biological: Fibrin Sealant 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), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
- A target bleeding site can be identified.
- Target bleeding site is identified on the cut raw liver surface (resection area).
- Target bleeding site has moderate bleeding according to the Investigator's judgment.
Key exclusion criteria (11 listed)
- Require hepatic resection 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 Fibrin Sealant 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 GrifolsCombination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site. | Biological | Fibrin Sealant Grifols |
| Surgicel®Also: Fibrillar absorbable hemostat, 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
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Time frame: From start of treatment until 4 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
4 secondary outcomes
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start
Time frame: From start of treatment until 3 minutes after treatment start
Time to Hemostasis
Time frame: From start of treatment until 10 minutes after treatment start
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Time frame: From start of treatment until 10 minutes after treatment start
Prevalence of Treatment Failures
Time frame: From start of treatment until 10 minutes after treatment start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant Grifols and Surgicel® in people with Parenchymous Tissue Surgical Bleeding, run by Instituto Grifols, S.A. at 33 sites in 4 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 8 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 33 sites in United States, Serbia, Hungary, Russia. 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 8 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?
Proportion of Subjects Achieving Hemostasis by Four 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 8 Feb 2017.