Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02233101 |
| Other study ID # |
RUSH2233 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 26, 2014 |
| Last updated |
October 23, 2017 |
| Start date |
June 2014 |
| Est. completion date |
August 2015 |
Study information
| Verified date |
October 2017 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the
different routes of drug administration are equivalent in terms of post-operative reduction
in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.
Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.
Description:
Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the
different routes of drug administration are equivalent in terms of post-operative reduction
in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.
Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.
Background/Scientific review:
Total hip or knee arthroplasty is associated with the risk of moderate to significant blood
loss. Techniques such as the use of antifibrinolytics or desmopressin, or normovolaemic
haemodilution have been used to reduce the need for allogeneic blood transfusion. Tranexamic
acid (TXA) has been used to reduce blood loss and transfusion requirement for total hip and
knee arthroplasty, with good results. Approximately one-third of patients undergoing total
joint replacement surgery require one to three units of blood postoperatively. Tranexamic
acid is a synthetic antifibrinolytic agent that has been successfully used intravenously to
control bleeding after total joint replacement. The use of TXA has been shown to
significantly reduce the need for blood products during total joint replacement1-4.
There are only a few studies directly comparing outcomes following the use of intravenous
tranexamic acid (IVTA) and oral tranexamic acid (OTA) in arthroplasty surgery. In the
randomized study by Zohar et al5. OTA (n = 20) was associated with significant allogeneic
blood sparing com- pared with controls (n = 20), but not when compared with short- and
long-term IVTA regimens. A recent randomized trial comparing OTA (n = 26) with placebo (n =
20) reported significant reductions in blood drained at 24 hours, and in the fall of both Hb
and Hct in the OTA group, without any significant difference in the requirement of
transfusion6.
Study Design: Prospective, randomized, single-blinded study
Treatment Groups:
1. Intravenous TXA Group - 1 gram IV bolus 10 minutes prior to incision
2. Oral TXA Group - 3 tablets (1950 mg) oral 2 hours prior to incision
Demographics/Patient Specifics: Age, Sex, ASA score, Weight, Height, Estimated
intra-operative blood loss, Intra-operative fluids (crystalloid, colloid), Operative time,
Hospitalization days, BMI, Pre-operative PT/INR, Pre-operative PTT, Pre-operative platelet
count
Outcome Measurements:
1. Post-operative reduction in Hgb - Measure pre-operative Hgb levels and post-operative
days 0, 1, 2, and 3 Hgb levels. Among the studies presented, they used different time
points to determine the reduction in Hgb. They either used the post-operative 12-hour
Hgb, post-operative day 4 Hgb, or the lowest Hgb during the hospitalization. Because we
rarely have patients stay until post-operative day 4, we will have to make our measure
off a different time period. We have patients get discharged as early as post-operative
day 1, so we'll probably have to use the post-operative day 1 Hgb level. We feel a Hgb
level difference of >1 g/dL is clinically significant.
2. Post-operative reduction in Hematocrit - Measure pre-operative and post-operative days
0, 1, 2, and 3 Hematocrit levels
3. Number of units transfused
4. Number of patients transfused
5. 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
6. Complications
1. DVT or PE
2. Return to the OR within 30 days
3. Re-admission within 30 days
4. Superficial infection
5. Deep infection
6. Periprosthetic fracture
7. Cerebrovascular accident or Transient ischemic attack
8. Dislocation
Risks/Benefits
The use of Tranexamic Acid is a standard of care used everyday in both primary and revision
surgeries, this includes both oral and intravenous forms of Tranexamic Acid. TXA side effects
include of nausea, vomiting and/or diarrhea. Gastrointestinal upset could occur with Oral
tranexamic acid.
The only risk involved is the potential for breach of confidentiality and/or privacy. Below
is a description of the procedure for maintaining confidentiality. There is no direct benefit
to the participants in this study.
Procedures for Maintaining Confidentiality
A breach of confidentiality and/or privacy is a risk of this study. To prevent this, all
collected data will be stored electronically in password-protected files to protect patient
identity and information. All information will be collected and reviewed by the research team
only. Data will be maintained on a password-protected computer that will be accessible only
to the study team. No patient identifiers will be maintained in the database.
