AnemiaPhase 4NCT02926651
Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty
A Phase 4 study testing Conventional Oral TXA (Tranexamic Acid) and Multi-Dose Oral TXA (Tranexamic Acid) in people with Anemia and Arthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Arthritis, Total Knee Arthroplasty
- What is being tested?
- Conventional Oral TXA (Tranexamic Acid) and Multi-Dose Oral TXA (Tranexamic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2017
- 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
- older than 18 years
- scheduled for a primary cemented TKA or cementless THA
- preoperative hematocrit less than 36%
Who cannot join
- Known allergy to TXA
- acquired disturbances of color vision
- refusal of blood products
- pre-operative use of anticoagulant therapy within five days before surgery
- a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack)
- pregnancy, breastfeeding
Show all 10Show fewer
- major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure)
- undergoing a revision TKA, revision THA, hip resurfacing, or Unicompartmental Knee Arthroplasty
- younger than 18 years old
- decline to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.
Read the detailed description
Total joint arthroplasty is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care at many institutions. Oral and intravenous TXA are equivalent, but oral TXA is cheaper and allows for ease of repeat dosing. Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard TXA dosing to risk stratified dosing of TXA. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen.
At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered, patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1 distribution of subjects between the two groups through blocked randomization, no later than the morning of surgery to either of the two treatment groups: Conventional Oral TXA Group or Multi-Dose Oral TXA Group.
- Conditions
- Anemia, Arthritis, Total Knee Arthroplasty, Total Hip Arthroplasty
- Being tested
- Conventional Oral TXA (Tranexamic Acid), Multi-Dose Oral TXA (Tranexamic Acid)
- Medical subject headings
- Anemia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Oral TXA (Tranexamic Acid)Drug
Three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1.
Multi-Dose Oral TXA (Tranexamic Acid)Drug
Three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Oral TXA, Total Hip Arthroplasty (THA) | Active comparator | THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. Receives: Drug: Conventional Oral TXA (Tranexamic Acid) |
| Conventional Oral TXA, Total Knee Arthroplasty (TKA) | Active comparator | TKA patients will be given three 650mg tablets of oral TXA (Tranexamic Acid) 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. Receives: Drug: Conventional Oral TXA (Tranexamic Acid) |
| Multi-Dose Oral TXA, Total Hip Arthroplasty (THA) | Experimental | THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. Receives: Drug: Multi-Dose Oral TXA (Tranexamic Acid) |
| Multi-Dose Oral TXA, Total Knee Arthroplasty (TKA) | Experimental | TKA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. Receives: Drug: Multi-Dose Oral TXA (Tranexamic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients transfused
Number of patients transfused per each of the 4 treatment arms
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of units Packed Red Blood Cells (PRBCs) transfused
Number of units Packed Red Blood Cells (PRBCs) transfused per each of the 4 treatment arms
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary outcomes (4)
Post-operative reduction in hemoglobin and hematocrit
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Calculated blood loss
Based on predicted blood volume and hemoglobin balance
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Cost comparison
Cost differences resulted from differences in the blood transfusion rate, length of hospital stay, and management of complications as well as from the cost of the TXA itself
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Complications
Deep Vein Thrombosis, Pulmonary Embolus, return to the Operating Room within 30 days, superficial or deep infection, and cerebrovascular accident, transient ischemic attack or Myocardial Infarction
Measured: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926651
- Sponsor's protocol ID
- 16060110
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2016
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT02926651
- Acronym / sponsor ID
- 16060110
- Conditions
- Anemia, Arthritis, Total Knee Arthroplasty, Total Hip Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Oct 2016 (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.
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.
Detailed description
Total joint arthroplasty is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care at many institutions. Oral and intravenous TXA are equivalent, but oral TXA is cheaper and allows for ease of repeat dosing. Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard TXA dosing to risk stratified dosing of TXA. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen.
At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered, patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1 distribution of subjects between the two groups through blocked randomization, no later than the morning of surgery to either of the two treatment groups: Conventional Oral TXA Group or Multi-Dose Oral TXA Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional Oral TXA, Total Hip Arthroplasty (THA) | Active comparator | Drug: Conventional Oral TXA (Tranexamic Acid)THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. |
| Conventional Oral TXA, Total Knee Arthroplasty (TKA) | Active comparator | Drug: Conventional Oral TXA (Tranexamic Acid)TKA patients will be given three 650mg tablets of oral TXA (Tranexamic Acid) 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. |
| Multi-Dose Oral TXA, Total Hip Arthroplasty (THA) | Experimental | Drug: Multi-Dose Oral TXA (Tranexamic Acid)THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. |
| Multi-Dose Oral TXA, Total Knee Arthroplasty (TKA) | Experimental | Drug: Multi-Dose Oral TXA (Tranexamic Acid)TKA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years
- scheduled for a primary cemented TKA or cementless THA
- preoperative hematocrit less than 36%
Key exclusion criteria (10 listed)
- Known allergy to TXA
- acquired disturbances of color vision
- refusal of blood products
- pre-operative use of anticoagulant therapy within five days before surgery
- a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack)
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 |
|---|---|---|
| Conventional Oral TXA (Tranexamic Acid)Three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. | Drug | Conventional Oral TXA, Total Hip Arthroplasty (THA), Conventional Oral TXA, Total Knee Arthroplasty (TKA) |
| Multi-Dose Oral TXA (Tranexamic Acid)Three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. | Drug | Multi-Dose Oral TXA, Total Hip Arthroplasty (THA), Multi-Dose Oral TXA, Total Knee Arthroplasty (TKA) |
Primary outcome
Number of patients transfused
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of patients transfused per each of the 4 treatment arms
Number of units Packed Red Blood Cells (PRBCs) transfused
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of units Packed Red Blood Cells (PRBCs) transfused per each of the 4 treatment arms
4 secondary outcomes
Post-operative reduction in hemoglobin and hematocrit
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Calculated blood loss
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Cost comparison
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Complications
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- 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.
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 Conventional Oral TXA (Tranexamic Acid) and Multi-Dose Oral TXA (Tranexamic Acid) in people with Anemia and Arthritis, run by Rush University Medical Center 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 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: withdrawn, as of the sponsor's last update on 26 Oct 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 patients transfused (time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from 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 26 Oct 2021.