Trial Outcomes & Findings for Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery (NCT NCT04754230)
NCT ID: NCT04754230
Last Updated: 2023-04-05
Results Overview
Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Postoperative Day 1 (assessed within first 24 hours following surgery)
Results posted on
2023-04-05
Participant Flow
Participant milestones
| Measure |
Normal Saline
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 16.2 • n=19 Participants
|
41.5 years
STANDARD_DEVIATION 18.6 • n=21 Participants
|
48.4 years
STANDARD_DEVIATION 18.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=19 Participants
|
10 Participants
n=21 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=19 Participants
|
11 Participants
n=21 Participants
|
19 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 1 (assessed within first 24 hours following surgery)Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD1
|
5.03 score on a scale
Standard Deviation 2.14
|
4.82 score on a scale
Standard Deviation 2.18
|
PRIMARY outcome
Timeframe: Postoperative Day 2Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD2
|
4.47 score on a scale
Standard Deviation 2.61
|
3.89 score on a scale
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: Postoperative Day 3Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD3
|
2.93 score on a scale
Standard Deviation 2.44
|
2.29 score on a scale
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: Postoperative Day 4Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD4
|
2.12 score on a scale
Standard Deviation 2.04
|
1.44 score on a scale
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: Postoperative Day 5Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD5
|
1.32 score on a scale
Standard Deviation 1.63
|
1.15 score on a scale
Standard Deviation 0.94
|
PRIMARY outcome
Timeframe: Postoperative Day 6Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD6
|
1.36 score on a scale
Standard Deviation 1.30
|
0.76 score on a scale
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: Postoperative Day 7Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Bleeding VAS - POD7
|
0.97 score on a scale
Standard Deviation 1.09
|
0.72 score on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Postoperative Day 2 through Postoperative Day 7Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Guaze Saturation VAS Though POD7
Postoperative day 2
|
5.16 score on a scale
Standard Deviation 2.89
|
4.56 score on a scale
Standard Deviation 2.50
|
|
Guaze Saturation VAS Though POD7
Postoperative day 3
|
3.03 score on a scale
Standard Deviation 3.05
|
2.09 score on a scale
Standard Deviation 1.81
|
|
Guaze Saturation VAS Though POD7
Postoperative day 4
|
1.74 score on a scale
Standard Deviation 2.10
|
0.76 score on a scale
Standard Deviation 1.34
|
|
Guaze Saturation VAS Though POD7
Postoperative day 5
|
1.11 score on a scale
Standard Deviation 1.56
|
0.40 score on a scale
Standard Deviation 0.86
|
|
Guaze Saturation VAS Though POD7
Postoperative day 6
|
0.99 score on a scale
Standard Deviation 1.45
|
0.29 score on a scale
Standard Deviation 1.81
|
|
Guaze Saturation VAS Though POD7
Postoperative day 7
|
0.80 score on a scale
Standard Deviation 1.05
|
0.28 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Day of surgery through 1 weekNumber of patients in each arm requiring evaluation by the resident service for bleeding concerns expressed by the recovery nurse (in PACU), had any follow-up visit or phone call outside of regularly scheduled follow-up
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Participants continue to receive their normal saline infusion during surgery.
|
1,000mg IV Tranexamic Acid
n=21 Participants
1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery.
|
|---|---|---|
|
Frequency of Participant Follow-up
PACU
|
0 Participants
|
0 Participants
|
|
Frequency of Participant Follow-up
Follow-up visit
|
0 Participants
|
1 Participants
|
|
Frequency of Participant Follow-up
Follow-up phone call
|
2 Participants
|
2 Participants
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1,000mg IV Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place