Trial Outcomes & Findings for TXA in Spinal Fusion (NCT NCT04272606)
NCT ID: NCT04272606
Last Updated: 2024-12-12
Results Overview
The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Results posted on
2024-12-12
Participant Flow
123 subjects were enrolled and consented. Prior to randomization, 37 subjects were excluded and did not get randomized.
37 subjects were excluded and not randomized due to the following reasons: * Exclusion criteria was found (14 subjects) * Surgery cancelled (8 subjects) * Subjects withdrew (5 subjects) * Surgery changed to min invasive and so subject did not qualify (3 subjects) * Surgeon decision (2 subjects) * trial on hold during randomization period (2 subjects) * study medication order problems (3 subjects)
Participant milestones
| Measure |
Treatment
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Treatment
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
TXA in Spinal Fusion
Baseline characteristics by cohort
| Measure |
Treatment
n=43 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
63 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
40 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reportedThe number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Outcome measures
| Measure |
Treatment
n=43 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Transfusion
Intraoperatively
|
7 Participants
|
6 Participants
|
|
Transfusion
Postoperatively (prior to discharge or at day 5, whichever occurred first)
|
9 Participants
|
8 Participants
|
|
Transfusion
Either Intraoperatively or Postoperatively
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reportedAmount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Outcome measures
| Measure |
Treatment
n=43 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Blood Loss
Intraoperatively
|
167 ml per instrumented vertebral level
Interval 87.0 to 250.0
|
110 ml per instrumented vertebral level
Interval 67.0 to 176.0
|
|
Blood Loss
Postoperatively (prior to discharge or at day 5, whichever occurred first)
|
128 ml per instrumented vertebral level
Interval 97.0 to 186.0
|
207 ml per instrumented vertebral level
Interval 132.0 to 258.0
|
|
Blood Loss
Either Intraoperatively or Postoperatively
|
305 ml per instrumented vertebral level
Interval 186.0 to 412.0
|
333 ml per instrumented vertebral level
Interval 241.0 to 428.0
|
PRIMARY outcome
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reportedDelirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
Outcome measures
| Measure |
Treatment
n=32 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=33 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Delirium Occurrence
|
7 participants with delirium
|
11 participants with delirium
|
SECONDARY outcome
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reportedSeverity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)
Outcome measures
| Measure |
Treatment
n=32 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=33 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Delirium Severity
|
1.10 3D-CAM Points
Interval 0.48 to 2.5
|
1.00 3D-CAM Points
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: Preoperatively and 24 hours postoperativelyMeasure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.
Outcome measures
| Measure |
Treatment
n=16 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=15 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Change in Interleukin-6 Concentration.
|
25.7 pg per ml
Interval 11.3 to 35.8
|
10.6 pg per ml
Interval 5.3 to 68.2
|
SECONDARY outcome
Timeframe: Days thru day of dischargeLength of postoperative stay prior to discharge in days
Outcome measures
| Measure |
Treatment
n=43 Participants
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 Participants
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Length of Postoperative Stay Prior to Discharge
|
3 Days
Interval 2.0 to 6.0
|
3 Days
Interval 2.0 to 5.0
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=43 participants at risk
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 participants at risk
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
0.00%
0/43 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
2.5%
1/40 • Number of events 1 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/43 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
2.5%
1/40 • Number of events 1 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
Other adverse events
| Measure |
Treatment
n=43 participants at risk
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
Tranexamic Acid: Antifibrinolytic Agent
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
Placebo
n=40 participants at risk
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
Saline Solution: Placebo
Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
|
|---|---|---|
|
Eye disorders
Vision Change
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
0.00%
0/40 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
|
Renal and urinary disorders
Renal Dysfunction
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
10.0%
4/40 • Number of events 4 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
|
Musculoskeletal and connective tissue disorders
Wound Complication
|
4.7%
2/43 • Number of events 2 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected on all subjects until their final postoperative follow up clinic visit (typically at or around 3 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place