Trial Outcomes & Findings for Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction (NCT NCT03413891)
NCT ID: NCT03413891
Last Updated: 2024-08-01
Results Overview
Any oral bleeding (early or delayed; minor, clinically relevant or major)
TERMINATED
PHASE4
222 participants
7 days: from randomization till end of follow-up
2024-08-01
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid Group
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
114
|
|
Overall Study
COMPLETED
|
106
|
112
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Tranexamic Acid Group
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.8 years
STANDARD_DEVIATION 8.8 • n=106 Participants
|
72.7 years
STANDARD_DEVIATION 10.7 • n=112 Participants
|
73.7 years
STANDARD_DEVIATION 9.8 • n=218 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=106 Participants
|
48 Participants
n=112 Participants
|
73 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=106 Participants
|
64 Participants
n=112 Participants
|
145 Participants
n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
106 Participants
n=106 Participants
|
112 Participants
n=112 Participants
|
218 Participants
n=218 Participants
|
|
New oral anticoagulants (NOAC)
rivaroxaban
|
38 Participants
n=106 Participants
|
40 Participants
n=112 Participants
|
78 Participants
n=218 Participants
|
|
New oral anticoagulants (NOAC)
apixaban
|
29 Participants
n=106 Participants
|
33 Participants
n=112 Participants
|
62 Participants
n=218 Participants
|
|
New oral anticoagulants (NOAC)
edoxaban
|
21 Participants
n=106 Participants
|
19 Participants
n=112 Participants
|
40 Participants
n=218 Participants
|
|
New oral anticoagulants (NOAC)
dabigatran
|
18 Participants
n=106 Participants
|
20 Participants
n=112 Participants
|
38 Participants
n=218 Participants
|
PRIMARY outcome
Timeframe: 7 days: from randomization till end of follow-upPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or had a protocol deviation.
Any oral bleeding (early or delayed; minor, clinically relevant or major)
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Number of Participants of Oral Bleeding
|
28 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day of extractionPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
The Procedural bleeding score assigned by operator (VAS 0-10): Visual analogue score: ranging from 0 (no bleeding) to 10 (unstoppable bleeding)
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Procedural Bleeding Score
|
4 score on a scale
Standard Deviation 1.78
|
4 score on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Early Bleeding
|
35 bleeding events
|
49 bleeding events
|
SECONDARY outcome
Timeframe: 6 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any oral bleeding occurring between day 2 and day 7
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Delayed Bleeding
|
11 bleeding events
|
36 bleeding events
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any oral bleeding not requiring unplanned medical contact
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Minor Bleeding
|
41 bleeding events
|
72 bleeding events
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any oral bleeding requiring unplanned medical contact
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Clinically-relevant Bleeding
|
5 bleeding events
|
13 bleeding events
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any oral bleeding requiring blood transfusion, hospitalization or resulting in death
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Major Bleeding
|
0 bleeding events
|
1 bleeding events
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
The Number of Reinterventions
|
7 number of reinterventions
|
13 number of reinterventions
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
The number of particpants with unplanned interruptions of direct oral anticoagulant therapy
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Unplanned medical contact by phone, new consultation or hospitalization with any health care professional (dentist, general practioner, maxillofacial surgeon)
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Number of Unplanned Medical Contacts
|
10 number of unplanned medical contacts
|
27 number of unplanned medical contacts
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Any non-oral bleeding
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Safety Outcome: Any Non-oral Bleeding
|
12 bleeding events
|
30 bleeding events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation.
Number of participants with thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism
Outcome measures
| Measure |
Tranexamic Acid Group
n=106 Participants
10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Tranexamic Acid: Mouthwash
|
Placebo Group
n=112 Participants
10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction).
Placebo: Mouthwash
|
|---|---|---|
|
Safety Outcome Number of Participants With Thrombotic Event
|
0 Participants
|
1 Participants
|
Adverse Events
Tranexamic Acid Group
Placebo Group
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