Adjunct to Hemostasis During Vascular SurgeryPhase 3NCT04083807
Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis
A Phase 3 study testing TISSEEL Lyo and Manual compression with surgical gauze pads in people with Adjunct to Hemostasis During Vascular Surgery, run by Baxter Healthcare Corporation at 5 sites in Russia.
Trial summary
The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjunct to Hemostasis During Vascular Surgery
- What is being tested?
- TISSEEL Lyo and Manual compression with surgical gauze pads
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesRussia
- Study dates
- 10 Jul 2019to 22 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Male or female ≥ 18 ages;
- Patients undergoing primary vascular surgery (i.e., conduit placement with an ePTFE graft), including the following:
- Arterio-arterial-bypass;
- Ilio-femoral bypass;
- Femoro-femoral bypass;
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- Ilio-popliteal bypass;
- Femoro-popliteal bypass;
- Femoro-tibial vessel bypass
- Arteriovenous shunting for dialysis access in the upper or lower extremity;
- Intraoperative inclusion criterion:
- Suture line bleeding eligible for study treatment is present after surgical hemostasis.
Who cannot join
- Concurrent participation in another clinical study treatment with another investigational drug or device within last 30 days;
- Other vascular procedures during the same surgical session;
- Arterio-arterial bypasses with more than two anastomoses;
- Haemoglobin <9.0 g/dL at screening;
- Pregnant or lactating women;
- Congenital or acquired coagulation disorders;
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- Prior kidney transplantation;
- Heparin-induced thrombocytopenia;
- Known prior exposure to aprotinin within the last 12 months;
- Known hypersensitivity to aprotinin, heparin, blood products or other components of the investigational product;
- Unwilling to receive blood products.
- Known severe congenital or acquired immunodeficiency;
- Prior radiation therapy to the operating field;
- Severe local inflammation at the operating field;
- Positive results of any of the following the blood tests: HIV, syphilis, hepatitis B, hepatitis C.
- Emergency surgery.
- Alcohol or drug abuse.
- Intraoperative exclusion criteria:
- Major intraoperative complications that required resuscitation or deviation from the planned surgical procedure;
- Intraoperative change in planned surgical procedure, which resulted in patient no longer meeting preoperative inclusion criteria or having preoperative exclusion criteria.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Baxter Investigational Site
Moscow
Baxter Investigational Site
Novosibirsk
Baxter Investigational Site
Rostov-on-Don
Baxter Investigational Site
Ryazan
Baxter Investigational Site
Saint Petersburg
About this study
Official title: A Randomised Controlled Multicenter Single-blinded Phase III Study to Evaluate the Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis During Vascular Surgery
The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.
- Being tested
- TISSEEL Lyo, Manual compression with surgical gauze pads
- Keywords
- haemostasis, tissue glue, tissue sealing, Ilio-femoral bypass, Femoro-femoral bypass, Ilio-popliteal bypass, Femoro-popliteal bypass, Femoro-tibial vessel bypass, Arterio-arterial-bypass, Arteriovenous shunting for dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TISSEEL LyoBiological
Also called Fibrin sealant Vapor Heated, Solvent/Detergent-Treated, with 500 IU/mL Thrombin
The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area and the mode of intended application, and the number of applications.. The guideline for sealing surfaces is one package of Tisseel Lyo 2 ml (i.e. 1 ml sealer protein solution plus 1 ml thrombin solution) is sufficient for a surface of at least 10 cm2.
Manual compression with surgical gauze padsProcedure or surgery
Surgical 4x4 inches gauze pads
| Study group | Role | What they receive |
|---|---|---|
| TISSEEL Lyo | Experimental | Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System. Receives: Biological: TISSEEL Lyo |
| Manual compression with surgical gauze pads | Active comparator | Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line. Receives: Procedure: Manual compression with surgical gauze pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving hemostasis at 4 minutes after treatment
Performed on suture line.
Measured: Day 0 (4 minutes post-treatment to closure of surgical wound)
Secondary outcomes (4)
Number of participants achieving hemostasis at 6 minutes after treatment
Performed on suture line.
Measured: Day 0 (6 minutes post-treatment to closure of surgical wound)
Number of participants achieving hemostasis at 10 minutes after treatment
Performed on suture line.
Measured: Day 0 (10 minutes post-treatment to closure of surgical wound)
Number of participants with intraoperative re-bleeding after hemostasis
Performed on suture line.
Measured: Day 0 (intraoperative)
Number of participants with postoperative re-bleeding after hemostasis
Performed on suture line. Requires surgical re-exploration.
Measured: Day 1 (postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start10 Jul 2019
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjunct to Hemostasis During 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083807
- Sponsor's protocol ID
- BXU529732
- Status last verified
- Dec 2019
- First submitted
- 23 Aug 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Multicenter Single-blinded Phase III Study to Evaluate the Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis During Vascular Surgery
- ClinicalTrials.gov ID
- NCT04083807
- Acronym / sponsor ID
- BXU529732
- Keywords
- haemostasis, tissue glue, tissue sealing, Ilio-femoral bypass, Femoro-femoral bypass, Ilio-popliteal bypass, Femoro-popliteal bypass, Femoro-tibial vessel bypass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 10 Sep 2019 (actual)
- 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.
The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TISSEEL Lyo | Experimental | Biological: TISSEEL LyoApplied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System. |
| Manual compression with surgical gauze pads | Active comparator | Procedure: Manual compression with surgical gauze padsTreated once intraoperatively with manual compression using surgical gauze pads at the study suture line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent;
- Male or female ≥ 18 ages;
- Patients undergoing primary vascular surgery (i.e., conduit placement with an ePTFE graft), including the following:
- Suture line bleeding eligible for study treatment is present after surgical hemostasis.
Key exclusion criteria (20 listed)
- Concurrent participation in another clinical study treatment with another investigational drug or device within last 30 days;
- Other vascular procedures during the same surgical session;
- Arterio-arterial bypasses with more than two anastomoses;
- Haemoglobin <9.0 g/dL at screening;
- Pregnant or lactating women;
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 |
|---|---|---|
| TISSEEL LyoAlso: Fibrin sealant Vapor Heated, Solvent/Detergent-Treated, with 500 IU/mL ThrombinThe dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area and the mode of intended application, and the number of applications.. The guideline for sealing surfaces is one package of Tisseel Lyo 2 ml (i.e. 1 ml sealer protein solution plus 1 ml thrombin solution) is sufficient for a surface of at least 10 cm2. | Biological | TISSEEL Lyo |
| Manual compression with surgical gauze padsSurgical 4x4 inches gauze pads | Procedure or surgery | Manual compression with surgical gauze pads |
Primary outcome
Number of participants achieving hemostasis at 4 minutes after treatment
Time frame: Day 0 (4 minutes post-treatment to closure of surgical wound)
Performed on suture line.
4 secondary outcomes
Number of participants achieving hemostasis at 6 minutes after treatment
Time frame: Day 0 (6 minutes post-treatment to closure of surgical wound)
Number of participants achieving hemostasis at 10 minutes after treatment
Time frame: Day 0 (10 minutes post-treatment to closure of surgical wound)
Number of participants with intraoperative re-bleeding after hemostasis
Time frame: Day 0 (intraoperative)
Number of participants with postoperative re-bleeding after hemostasis
Time frame: Day 1 (postoperative)
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 6 Dec 2019.
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.
5 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 TISSEEL Lyo and Manual compression with surgical gauze pads in people with Adjunct to Hemostasis During Vascular Surgery, run by Baxter Healthcare Corporation at 5 sites in Russia.
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 12 inclusion and 20 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in 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?
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?
Number of participants achieving hemostasis at 4 minutes after treatment (time frame: Day 0 (4 minutes post-treatment to closure of surgical wound)). 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 6 Dec 2019.