Vascular Surgical BleedingPhase 3NCT01662856
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
A Phase 3 study testing Fibrin Sealant Grifols and Manual Compression in people with Vascular Surgical Bleeding, run by Instituto Grifols, S.A. at 38 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Surgical Bleeding
- What is being tested?
- Fibrin Sealant Grifols and Manual Compression
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 38 sitesin 4 countries
- Study dates
- Aug 2012to 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), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
- Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
- A target bleeding site can be identified.
- Target bleeding site has moderate arterial bleeding.
Who cannot join
- Undergoing a re-operative procedure.
- Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
- Have an infection in the anatomic surgical area.
- Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
Show all 11Show fewer
- Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
- Target bleeding site cannot be identified.
- Target bleeding site has mild or severe arterial bleeding.
- Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.
Trial locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
United States27 sites
140
Atlanta, Georgia, 30303
129
Baltimore, Maryland, 21201
146
Baton Rouge, Louisiana, 70809
135
Bethesda, Maryland, 20889
102
Boston, Massachusetts, 02118
409
Dayton, Ohio, 45409
407
Florence, Alabama, 35630
147
Fort Worth, Texas, 76107
402
Houston, Texas, 77024
114
Iowa City, Iowa, 52242
149
Jacksonville, Florida, 32207
148
Jacksonville, Florida, 32216
110
Lexington, Kentucky, 40536
111
Madison, Wisconsin, 53792
406
Manhasset, New York, 11030
132
New Orleans, Louisiana, 70112
125
Palo Alto, California, 94304
100, 128
Pittsburgh, Pennsylvania, 15212
139
Salt Lake City, Utah, 84132-3201
119
San Diego, California, 92120
103
Seattle, Washington, 98104
113
Stony Brook, New York, 11794
138
Tacoma, Washington, 98431
137
Tampa, Florida, 33606
142
The Bronx, New York, 10467-2401
104
Toledo, Ohio, 43606
115
West Reading, Pennsylvania, 19611
Russia5 sites
540
Novosibirsk, 630055
542
Rostov-on-Don, 344022
541
Saint Petersburg, 194354
543
Saint Petersburg, 195271
544
Saint Petersburg, 197374
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 Peripheral Vascular Surgery
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
- Conditions
- Vascular Surgical Bleeding
- Being tested
- Fibrin Sealant Grifols, Manual Compression
- Keywords
- Vascular Surgery, Fibrin Sealant, Polytetrafluoroethylene (PTFE) grafts
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).
Manual CompressionProcedure or surgery
Direct manual compression of target bleeding site with gauze/laparotomy pads.
| 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 |
| Manual Compression | Active comparator | Direct manual compression of target bleeding site with gauze/laparotomy pads. Receives: Procedure: Manual Compression |
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 (3)
Time to Hemostasis (TTH)
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.
All calculations were performed using SAS PROC LIFETEST
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 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 posted10 Aug 2012 (estimated)
- Study startAug 2012
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular 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
- 225 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
- NCT01662856
- Sponsor's protocol ID
- IG1101
- Status last verified
- Feb 2017
- First submitted
- 7 Aug 2012
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 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 Peripheral Vascular Surgery
- ClinicalTrials.gov ID
- NCT01662856
- Acronym / sponsor ID
- IG1101
- Conditions
- Vascular Surgical Bleeding
- Keywords
- Vascular Surgery, Fibrin Sealant, Polytetrafluoroethylene (PTFE) grafts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
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). |
| Manual Compression | Active comparator | Procedure: Manual CompressionDirect manual compression of target bleeding site with gauze/laparotomy pads. |
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), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
- Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
- A target bleeding site can be identified.
- Target bleeding site has moderate arterial bleeding.
Key exclusion criteria (11 listed)
- Undergoing a re-operative procedure.
- Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
- Have an infection in the anatomic surgical area.
- Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
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). | Biological | Fibrin Sealant Grifols |
| Manual CompressionDirect manual compression of target bleeding site with gauze/laparotomy pads. | Procedure or surgery | Manual Compression |
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.
3 secondary outcomes
Time to Hemostasis (TTH)
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 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38695613Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
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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.
38 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 Manual Compression in people with Vascular Surgical Bleeding, run by Instituto Grifols, S.A. at 38 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Russia, 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 6 Apr 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?
On the ClinicalTrials.gov record for NCT01662856, which also lists 1 linked publication.
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 6 Apr 2017.