Total Joint ArthroplastyPhase 4NCT01636414
Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
A Phase 4 study testing Hemovac drain, Re-infusion drain and Tranexamic drain in people with Total Joint Arthroplasty, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%. The risks of allogenic blood transfusion are well documented in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Joint Arthroplasty
- What is being tested?
- Hemovac drain, Re-infusion drain and Tranexamic drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2015
- 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
- Patients presenting for primary unilateral hip or knee arthroplasty
- > 18 years of age
- Preoperative hemoglobin on day of surgery > 10mg/dL
Who cannot join
- Patients with a preoperative Hgb < 10mg/dL
- Patients who are unwilling to consent to blood transfusions
- Patients with a history of bleeding disorder
- Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
- Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
- Patients with platelet counts < 100,000
Show all 19Show fewer
- Patients with kidney disease (Serum Cr > 1.2)
- Patients with end stage renal disease or on hemodialysis
- Patients with renal transplant
- Patients presenting for bilateral total hip or knee arthroplasty
- Patients presenting for conversion or revision total hip or knee procedures
- Patients donating pre-autologous blood
- Patients with primary hematologic disease or malignancy
- Patients with allergy to Tranexamic Acid
- Patients with hepatic disease
- Patients not discontinuing steroid use prior to surgery
- Patients with religious beliefs/practices prohibiting blood transfusions
- Patients with cognitive impairment
- Patients who are terminally ill
Trial locations and contacts
1 site in 1 country.
About this study
It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.
The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.
The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.
- Conditions
- Total Joint Arthroplasty
- Being tested
- Hemovac drain, Re-infusion drain, Tranexamic drain
- Keywords
- Total joint arthroplasty, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemovac drainProcedure or surgery
The Hemovac drain is a device placed under your skin used to collect blood during surgery.
Re-infusion drainProcedure or surgery
This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
Tranexamic drainProcedure or surgery
Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Hemovac drain | Active comparator | Not described Receives: Procedure: Hemovac drain |
| Re-infusion drain | Active comparator | Not described Receives: Procedure: Re-infusion drain |
| Tranexamic drain | Active comparator | Not described Receives: Procedure: Tranexamic drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Transfusion
Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
Measured: Inpatient Postoperative, on average 3 days after surgery
Change in Hemoglobin Level
Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.
Measured: Post-operative on day 2 (first day after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionOct 2015
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 Total Joint ArthroplastyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636414
- Sponsor's protocol ID
- 051114B
- Status last verified
- Jul 2016
- First submitted
- 14 Jun 2012
- Last updated
- 22 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01636414
- Acronym / sponsor ID
- 051114B
- Conditions
- Total Joint Arthroplasty
- Keywords
- Total joint arthroplasty, blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 25 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.
The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.
The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemovac drain | Active comparator | Procedure: Hemovac drain |
| Re-infusion drain | Active comparator | Procedure: Re-infusion drain |
| Tranexamic drain | Active comparator | Procedure: Tranexamic drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting for primary unilateral hip or knee arthroplasty
- > 18 years of age
- Preoperative hemoglobin on day of surgery > 10mg/dL
Key exclusion criteria (19 listed)
- Patients with a preoperative Hgb < 10mg/dL
- Patients who are unwilling to consent to blood transfusions
- Patients with a history of bleeding disorder
- Patients on anticoagulation therapy preoperatively (ASA 325mg, Plavix or Coumadin)
- Patients with a history of Thromboembolic events ( DVT, PE, CVA MI)
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 |
|---|---|---|
| Hemovac drainThe Hemovac drain is a device placed under your skin used to collect blood during surgery. | Procedure or surgery | Hemovac drain |
| Re-infusion drainThis device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion. | Procedure or surgery | Re-infusion drain |
| Tranexamic drainTranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. | Procedure or surgery | Tranexamic drain |
Primary outcome
Blood Transfusion
Time frame: Inpatient Postoperative, on average 3 days after surgery
Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups
Change in Hemoglobin Level
Time frame: Post-operative on day 2 (first day after surgery)
Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemovac drain, Re-infusion drain and Tranexamic drain in people with Total Joint Arthroplasty, run by OrthoCarolina Research Institute, Inc. 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 3 inclusion and 19 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 Aug 2016. 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 25 Apr 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?
Blood Transfusion (time frame: Inpatient Postoperative, on average 3 days after surgery). The study lists 2 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 22 Aug 2016.