Blood LossPhase 4NCT01472913
Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength
A Phase 4 study testing Fibrin sealant and Saline water in people with Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss
- What is being tested?
- Fibrin sealant and Saline water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Sep 2013
- Phase
- Phase 4
- 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
- Elective bilateral knee arthroplasty
- Must speak and understand Danish
- Musk be able to gave oral and written consent.
- Females must be post-menopausal, and last menstruation must be minimum of one year ago.
Who cannot join
- Alcohol or medicine abuse
- Treatment with opioids
- Allergy to local anaesthetics
- Allergy to active substances i fibrin sealant
- Age below 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength
The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.
- Conditions
- Blood Loss
- Being tested
- Fibrin sealant, Saline water
- Keywords
- Prospective randomised double-blind study, Fibrin sealant, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications
- Medical subject headings
- Hemorrhage, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin sealantDrug
Also called Evicel, ATC-kode B02BC30
Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.
Saline waterDrug
Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Sealent | Active comparator | Not described Receives: Drug: Fibrin sealant |
| Saline water | Placebo comparator | Not described Receives: Drug: Saline water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
24 hours postopertive blood loss estimated by drains from each of the knees .
Measured: 24 hours postoperative
Secondary outcomes (4)
Pain
2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.
Measurement of postoperative pain is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
Measured: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.
swelling
2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.
Measurement of postoperative swelling is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. The swelling is measured as the difference of circumference 1 cm proximal of the patella 2-3 weeks before surgery and at the outlined postoperative times.
Measured: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day
Range of Movement (ROM)
2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.
Measurement of postoperative ROM is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
Measured: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day
Strength
2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.
Measurement of postoperative strength is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
Measured: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Skovgaard Nielsen, Hvidovre University Hospital
- Investigators
- Christian Skovgaard Nielsen, M.D, Principal investigator, Hvidovre University HospitalHenrik Husted, M.D., Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472913
- Sponsor's protocol ID
- H-A-2009-69
- Status last verified
- Apr 2015
- First submitted
- 11 Oct 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength
- ClinicalTrials.gov ID
- NCT01472913
- Acronym / sponsor ID
- H-A-2009-69
- Conditions
- Blood Loss
- Keywords
- Prospective randomised double-blind study, Fibrin sealant, Bilateral simultaneous total knee arthroplasty, Blood loss, Postoperative pain, Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Nov 2011 (estimated)
- 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 purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealent | Active comparator | Drug: Fibrin sealant |
| Saline water | Placebo comparator | Drug: Saline water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective bilateral knee arthroplasty
- Must speak and understand Danish
- Musk be able to gave oral and written consent.
- Females must be post-menopausal, and last menstruation must be minimum of one year ago.
Key exclusion criteria (5 listed)
- Alcohol or medicine abuse
- Treatment with opioids
- Allergy to local anaesthetics
- Allergy to active substances i fibrin sealant
- Age below 18
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 sealantAlso: Evicel, ATC-kode B02BC30Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee. | Drug | Fibrin Sealent |
| Saline waterSame procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo). | Drug | Saline water |
Primary outcome
Blood loss
Time frame: 24 hours postoperative
24 hours postopertive blood loss estimated by drains from each of the knees .
4 secondary outcomes
Pain
Time frame: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.
swelling
Time frame: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day
Range of Movement (ROM)
Time frame: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day
Strength
Time frame: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day
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 22 Apr 2015.
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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.
Christian Skovgaard Nielsen, M.D principal investigator
Hvidovre University Hospital
Henrik Husted, M.D. principal investigator
Hvidovre University Hospital
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 Fibrin sealant and Saline water in people with Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 22 Apr 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
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?
Blood loss (time frame: 24 hours postoperative). 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 22 Apr 2015.