Operation Site BleedPhase 4ControlNCT00652314
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
A Phase 4 study testing Thrombi-Gel in people with Operation Site Bleed, run by Vascular Solutions LLC at 7 sites in United States.
Trial summary
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Operation Site Bleed
- What is being tested?
- Thrombi-Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2008to Jan 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 years of age or older
- The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or vascular surgical procedure (neurosurgical, ophthalmic or urological procedures must be excluded)
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
- Inclusion criteria to be determined during the surgical procedure:
- 1. The subject has an intraoperative bleeding site which the surgeon is unable or unwilling to easily control with conventional methods (cautery, sutures)
Who cannot join
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has a known allergy to bovine derived products or any other materials used in the Thrombi-Gel product
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
- The subject has received antibiotic solutions/powders at the intended application site
Show all 10Show fewer
- The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
- The subject is unavailable for follow-up
- The subject is currently participating in another investigational device or drug trial
- The subject has previously participated in this trial (Protocol 0307) or the Thrombi-Paste trial (Protocol 0507)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Michigan Vascular Research Center
Flint, Michigan, 48507
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Southwest Regional Clinical Research
Lubbock, Texas, 79412
Texas Tech University Health Sciences Center
Lubbock, Texas, 79415
Sanford Clinic
Sioux Falls, South Dakota, 57104
Southern Illinois University School of Medicine
Springfield, Illinois, 66702
About this study
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.
Read the detailed description
This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an absorbable hemostat in the surgical patient population.
Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization.
A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.
- Conditions
- Operation Site Bleed
- Being tested
- Thrombi-Gel
- Keywords
- Hemostatic products, Surgical hemostasis, Thrombi-gel, Gelatin Sponge, Time to hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombi-GelDevice
Also called Gelatin Sponge (Gelfoam) plus thrombin
Applicaton of Hemostatic product during surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 - Thrombi-gel treatment | Experimental | Thrombi-gel treatment Receives: Device: Thrombi-Gel |
| 2 - Gelatin Sponge (Gelfoam) | Active comparator | Gelatin Sponge (Gelfoam) plus thrombin Receives: Device: Thrombi-Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.
Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.
Measured: Time to hemostasis (minutes)
Secondary outcomes (4)
Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)
Measured: Procedure, up to 6 minutes post procedure
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.
Measured: Procedure (application through end of procedure)
Safety: Incidence Rate of Device-related Adverse Events
Measured: Procedure, up to 60 days post procedure
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Measured: 0 day, 30 day, and 60 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionJan 2010
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 Operation Site BleedStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Robert Dolan, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652314
- Sponsor's protocol ID
- 0307
- Other IDs
- The CONTROL Study
- Acronym
- Control
- Status last verified
- Feb 2016
- First submitted
- 28 Mar 2008
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
- ClinicalTrials.gov ID
- NCT00652314
- Acronym / sponsor ID
- Control / 0307
- Conditions
- Operation Site Bleed
- Keywords
- Hemostatic products, Surgical hemostasis, Thrombi-gel, Gelatin Sponge, Time to hemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Vascular Solutions LLCIndustry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.
Detailed description
This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an absorbable hemostat in the surgical patient population.
Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization.
A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Thrombi-gel treatment | Experimental | Device: Thrombi-GelThrombi-gel treatment |
| 2 - Gelatin Sponge (Gelfoam) | Active comparator | Device: Thrombi-GelGelatin Sponge (Gelfoam) plus thrombin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is 18 years of age or older
- The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or vascular surgical procedure (neurosurgical, ophthalmic or urological procedures must be excluded)
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
- 1. The subject has an intraoperative bleeding site which the surgeon is unable or unwilling to easily control with conventional methods (cautery, sutures)
Key exclusion criteria (10 listed)
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has a known allergy to bovine derived products or any other materials used in the Thrombi-Gel product
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
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 |
|---|---|---|
| Thrombi-GelAlso: Gelatin Sponge (Gelfoam) plus thrombinApplicaton of Hemostatic product during surgery | Device | 1 - Thrombi-gel treatment, 2 - Gelatin Sponge (Gelfoam) |
Primary outcome
The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.
Time frame: Time to hemostasis (minutes)
Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.
4 secondary outcomes
Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)
Time frame: Procedure, up to 6 minutes post procedure
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Time frame: Procedure (application through end of procedure)
Safety: Incidence Rate of Device-related Adverse Events
Time frame: Procedure, up to 60 days post procedure
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Time frame: 0 day, 30 day, and 60 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert Dolan, MD principal investigator
Lahey Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thrombi-Gel in people with Operation Site Bleed, run by Vascular Solutions LLC at 7 sites in United States.
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 6 inclusion and 10 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Mar 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 Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings. (time frame: Time to hemostasis (minutes)). 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 7 Mar 2016.