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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
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In patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased risk of thrombo-embolic events. Therefore, an optimal strategy to minimize bleeding events after tooth extractions is required. In this study, the investigators want to assess whether adding tranexamic acid mouthwash reduces the number of bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth extraction.
Interventional phase IV, randomized, double-blind, placebo-controlled trial:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | 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). |
|
| Tranexamic Acid Group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Mouthwash |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants of Oral Bleeding | Any oral bleeding (early or delayed; minor, clinically relevant or major) | 7 days: from randomization till end of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Bleeding Score | The Procedural bleeding score assigned by operator (VAS 0-10): Visual analogue score: ranging from 0 (no bleeding) to 10 (unstoppable bleeding) | Day of extraction |
| Early Bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Any Non-oral Bleeding | Any non-oral bleeding | 7 days |
| Safety Outcome Number of Participants With Thrombotic Event | Number of participants with thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Verhamme, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33939696 | Result | Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, Verhamme P. Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial. PLoS Med. 2021 May 3;18(5):e1003601. doi: 10.1371/journal.pmed.1003601. eCollection 2021 May. |
| Label | URL |
|---|---|
| Pmed publication | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized patients except those who were lost to follow-up or who had a protocol violation were included in the full analysis set.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants of Oral Bleeding | Any oral bleeding (early or delayed; minor, clinically relevant or major) | Full analysis set: all randomized patients except for those who were lost to follow-up or had a protocol deviation. | Posted | Count of Participants | Participants | 7 days: from randomization till end of follow-up |
|
From inclusion in the study until patients last visit:in total 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs. Barbara Debaveye | University Hospitals Leuven | 003216 341463 | barbara.debaveye@uzleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 | Jan 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Other | Mouthwash |
|
Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
| 2 days |
| Delayed Bleeding | Any oral bleeding occurring between day 2 and day 7 | 6 days |
| Minor Bleeding | Any oral bleeding not requiring unplanned medical contact | 7 days |
| Clinically-relevant Bleeding | Any oral bleeding requiring unplanned medical contact | 7 days |
| Major Bleeding | Any oral bleeding requiring blood transfusion, hospitalization or resulting in death | 7 days |
| The Number of Reinterventions | Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon | 7 days |
| The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy | The number of particpants with unplanned interruptions of direct oral anticoagulant therapy | 7 days |
| Number of Unplanned Medical Contacts | Unplanned medical contact by phone, new consultation or hospitalization with any health care professional (dentist, general practioner, maxillofacial surgeon) | 7 days |
| 7 days |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| New oral anticoagulants (NOAC) | Count of Participants | Participants |
|
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| Secondary | Procedural Bleeding Score | The Procedural bleeding score assigned by operator (VAS 0-10): Visual analogue score: ranging from 0 (no bleeding) to 10 (unstoppable bleeding) | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Mean | Standard Deviation | score on a scale | Day of extraction |
|
|
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| Secondary | Early Bleeding | Any oral bleeding occurring after the extraction up to and including day 1 after the extraction | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 2 days |
|
|
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| Secondary | Delayed Bleeding | Any oral bleeding occurring between day 2 and day 7 | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 6 days |
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| Secondary | Minor Bleeding | Any oral bleeding not requiring unplanned medical contact | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 7 days |
|
|
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| Secondary | Clinically-relevant Bleeding | Any oral bleeding requiring unplanned medical contact | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 7 days |
|
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| Secondary | Major Bleeding | Any oral bleeding requiring blood transfusion, hospitalization or resulting in death | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 7 days |
|
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| Secondary | The Number of Reinterventions | Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | number of reinterventions | 7 days |
|
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| Secondary | The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy | The number of particpants with unplanned interruptions of direct oral anticoagulant therapy | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Count of Participants | Participants | 7 days |
|
|
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| Secondary | Number of Unplanned Medical Contacts | Unplanned medical contact by phone, new consultation or hospitalization with any health care professional (dentist, general practioner, maxillofacial surgeon) | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | number of unplanned medical contacts | 7 days |
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| Other Pre-specified | Safety Outcome: Any Non-oral Bleeding | Any non-oral bleeding | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Number | bleeding events | 7 days |
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| Other Pre-specified | Safety Outcome Number of Participants With Thrombotic Event | Number of participants with thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism | Full analysis set: all randomized patients except for those who were lost to follow-up or who had a protocol violation. | Posted | Count of Participants | Participants | 7 days |
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|
|
| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | 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 | 0 | 114 | 0 | 114 | 0 | 114 |
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| edoxaban |
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| dabigatran |
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