Blood LossPhase 4NCT00990288
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
A Phase 4 study testing Hemostatic Matrix in people with Blood Loss, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Loss
- What is being tested?
- Hemostatic Matrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single Knee replacement for arthritis of the knee
Who cannot join
- No inflammatory arthritis (ie. Rheumatoid arthritis)
- No allergies to cow meat (bovine allergies
- No history of bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.
Read the detailed description
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.
Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
- Conditions
- Blood Loss
- Being tested
- Hemostatic Matrix
- Keywords
- To decrease blood loss during knee surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic MatrixDrug
Also called "FloSeal", a thrombin and collagen based agent
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
| Study group | Role | What they receive |
|---|---|---|
| Hemostatic Matrix | Experimental | 2 vials of Floseal applied once at the end of surgery Receives: Drug: Hemostatic Matrix |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin on Day 0 Compared to Preoperatively
Measured: preoperatively and on the day of surgery
Change in Hemoglobin on Day 0 Compared to Preoperatively
Measured: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Measured: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Measured: preoperatively and 1 day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Measured: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Measured: preoperatively and two days after surgery
Drain Output
Measured: 24 hours postoperatively
Autologous Amount of Transfusion
Measured: three days postoperatively
Homologous Amount of Transfusion
Measured: three days postoperatively
Secondary outcomes (4)
Range of Motion on Day 3
Measured: 3days postoperatively
Visual Analog Pain Scale on Day 3
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.
The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Measured: 3 days postoperatively
Range of Motion at Six Weeks
Measured: 6 weeks postoperatively
Visual Analog Pain Scale at 6 Weeks
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.
The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionAug 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 Blood LossStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Mark P Figgie, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990288
- Sponsor's protocol ID
- 26078
- Status last verified
- Nov 2017
- First submitted
- 5 Oct 2009
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00990288
- Acronym / sponsor ID
- 26078
- Conditions
- Blood Loss
- Keywords
- To decrease blood loss during knee surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 12 Dec 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 determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.
Detailed description
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.
Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostatic Matrix | Experimental | Drug: Hemostatic Matrix2 vials of Floseal applied once at the end of surgery |
| Control | No intervention | –No intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Single Knee replacement for arthritis of the knee
Key exclusion criteria (3 listed)
- No inflammatory arthritis (ie. Rheumatoid arthritis)
- No allergies to cow meat (bovine allergies
- No history of bleeding disorders
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 |
|---|---|---|
| Hemostatic MatrixAlso: "FloSeal", a thrombin and collagen based agentFloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface. | Drug | Hemostatic Matrix |
Primary outcome
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and on the day of surgery
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and 1 day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Drain Output
Time frame: 24 hours postoperatively
Autologous Amount of Transfusion
Time frame: three days postoperatively
Homologous Amount of Transfusion
Time frame: three days postoperatively
4 secondary outcomes
Range of Motion on Day 3
Time frame: 3days postoperatively
Visual Analog Pain Scale on Day 3
Time frame: 3 days postoperatively
Range of Motion at Six Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale at 6 Weeks
Time frame: 6 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- 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.
Mark P Figgie, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemostatic Matrix in people with Blood Loss, run by Hospital for Special Surgery, New York at 1 site 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 1 inclusion and 3 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Dec 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?
Change in Hemoglobin on Day 0 Compared to Preoperatively (time frame: preoperatively and on the day of surgery). The study lists 9 primary outcomes in all. 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 12 Dec 2017.