Target Bleeding Site During Peripheral Vascular SurgeryPhase 2/3NCT00684047
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
A Phase 2/3 study testing FS Grifols and Manual Compression in people with Target Bleeding Site During Peripheral Vascular Surgery, run by Instituto Grifols, S.A. at 19 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Target Bleeding Site During Peripheral Vascular Surgery
- What is being tested?
- FS Grifols and Manual Compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Feb 2008to May 2014
- Phase
- Phase 2/3
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are male or female
- Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom)
- Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
- Have hemoglobin ≥ 9.0 g/dL
- Have platelet count > 70 x 10^3/mm^3
- Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection:
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- Carotid endarterectomy requiring patch angioplasty
- Carotid-subclavian bypass grafting
- Axillo-femoral bypass grafting
- Abdominal aortic aneurysm resection and graft replacement
- Aorto-mesenteric bypass grafting
- Aorto-celiac bypass grafting
- Aorto-uni-iliac bypass grafting
- Aorto-bi-iliac bypass grafting
- Aorto-uni-femoral bypass grafting
- Aorto-bi-femoral bypass grafting
- Iliac aneurysm resection and graft replacement
- Femoral aneurysm resection and graft replacement
- Femoral-femoral bypass grafting
- Femoral-popliteal bypass grafting
- Renal arterial revascularization (bypass grafting)
- Renal arterial revascularization (endarterectomy with patch angioplasty)
- Popliteal artery revascularization (bypass grafting)
- Popliteal artery revascularization (endarterectomy with patch angioplasty)
- Femoral endarterectomy with patch angioplasty
- Ilio-femoral bypass grafting
- Intra-operative inclusion criterion:
- A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment
Who cannot join
- Weighed < 20 kg
- Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
- Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
- Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range
- Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
- Have an infection in the anatomical surgical area
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- Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product
- Unwilling to receive blood products
- Have positive bleeding history
- Female who was pregnant or nursing
- Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
- Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
- Were previously included in this clinical trial (protocol number IG402)
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United Kingdom8 sites
Doncaster Royal Infirmary Hospital
Doncaster, DN2 5LT
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, B15 2WB
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ
Hull Royal Infirmary
Hull, HU3 2JZ
Leeds General Infirmary
Leeds, LS1 3EX
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
St. George's Hospital
Tooting, SW17 ORE
Spain6 sites
Hospital Clinic i Provincial
Barcelona, 08036
Hospital de Sabadell
Barcelona, 08208
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Son Espases
Palma de Mallorca, 07014
Clinica Universitaria de Navarra
Pamplona, 31008
Hospital Universitario Marques de Valdecilla
Santander, 39008
Canada5 sites
Schulich School of Medicine, London Health Sciences Center
London, Ontario, N6A 5W9
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Prospective, Single-blind, Randomized, Phase II/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 evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
Read the detailed description
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
- Being tested
- FS Grifols, Manual Compression
- Keywords
- Fibrin Sealant, Hemostasis, Peripheral Vascular Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS GrifolsBiological
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
FS GrifolsBiological
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Manual CompressionProcedure or surgery
Manual Compression. Primary Part (II)
| Study group | Role | What they receive |
|---|---|---|
| FS Grifols Preliminary Part (I) | Experimental | Open label administration of FS Grifols to all subjects Receives: Biological: FS Grifols |
| FS Grifols Primary Part (II) | Experimental | Single-blind, randomized (2:1) Receives: Biological: FS Grifols |
| Manual Compression Primary Part (II) | Active comparator | Single-blind, randomized (2:1) Receives: Procedure: Manual Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint is Time to Hemostasis.
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
Measured: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
Secondary outcomes (2)
Proportions of Subjects Achieving Hemostasis
The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)
Measured: 10 minutes from the start of treatment application at the target bleeding site
Prevalence of Treatment Failures
The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)
Measured: 10 minutes from the start of treatment application at the target bleeding site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2014
- Study completionMay 2014
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 Target Bleeding Site During Peripheral Vascular SurgeryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Kozloff, MD, Study director, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684047
- Sponsor's protocol ID
- IG402
- Status last verified
- Dec 2015
- First submitted
- 20 May 2008
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Randomized, Phase II/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
- NCT00684047
- Acronym / sponsor ID
- IG402
- Keywords
- Fibrin Sealant, Hemostasis, Peripheral Vascular Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 25 Jan 2016
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 evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
Detailed description
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FS Grifols Preliminary Part (I) | Experimental | Biological: FS GrifolsOpen label administration of FS Grifols to all subjects |
| FS Grifols Primary Part (II) | Experimental | Biological: FS GrifolsSingle-blind, randomized (2:1) |
| Manual Compression Primary Part (II) | Active comparator | Procedure: Manual CompressionSingle-blind, randomized (2:1) |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- Are male or female
- Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom)
- Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
- Have hemoglobin ≥ 9.0 g/dL
- Have platelet count > 70 x 10^3/mm^3
Key exclusion criteria (13 listed)
- Weighed < 20 kg
- Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
- Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
- Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range
- Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
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 |
|---|---|---|
| FS GrifolsFibrin Sealant Grifols (FS Grifols). Preliminary Part (I) | Biological | FS Grifols Preliminary Part (I) |
| FS GrifolsFibrin Sealant Grifols (FS Grifols). Primary Part (II) | Biological | FS Grifols Primary Part (II) |
| Manual CompressionManual Compression. Primary Part (II) | Procedure or surgery | Manual Compression Primary Part (II) |
Primary outcome
The Primary Efficacy Endpoint is Time to Hemostasis.
Time frame: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
2 secondary outcomes
Proportions of Subjects Achieving Hemostasis
Time frame: 10 minutes from the start of treatment application at the target bleeding site
Prevalence of Treatment Failures
Time frame: 10 minutes from the start of treatment application at the target bleeding site
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- 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.
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.
Louis Kozloff, MD study director
Independent
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FS Grifols and Manual Compression in people with Target Bleeding Site During Peripheral Vascular Surgery, run by Instituto Grifols, S.A. at 19 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 28 inclusion and 13 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Spain, Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Jan 2016). 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?
The Primary Efficacy Endpoint is Time to Hemostasis. (time frame: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.). 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 NCT00684047, 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 25 Jan 2016.