Evidence map›Paper›PMID 33939696›Full record

Trial reportPLoS medicine2021

Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial.

Anna Ockerman, Isabel Miclotte, Maarten Vanhaverbeke, Thomas Vanassche, Ann Belmans, Jan Vanhove, Joeri Meyns, Nasser Nadjmi, Geert Van Hemelen, Patrick Winderickx and 3 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03413891 (Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03413891 phase4terminatednot on this map

Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2018 to 2020Enrolled222ConditionsTooth ExtractionArmsTranexamic Acid, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Article
  3. Post-extraction bleeding in patients on direct oral anticoagulants.Journal of the Korean Association of Oral and Maxillofacial Surgeons · 2024
    Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Anna OckermanOral and Maxillofacial Surgery-Imaging and Pathology Research Group, Department of Imaging and Pathology, University of Leuven and Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-0635-2774
Isabel MiclotteOral and Maxillofacial Surgery-Imaging and Pathology Research Group, Department of Imaging and Pathology, University of Leuven and Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.
Maarten VanhaverbekeDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-4385-7069
Thomas VanasscheDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-7404-8918
Ann BelmansLeuven Biostatistics and Statistical Bioinformatics Centre, Department of Public Health and Primary Care, University of Leuven, Leuven, Belgium.ORCID 0000-0003-1332-2917
Jan VanhoveOral & Maxillofacial Surgery, Regional Hospital Heilig Hart Leuven, Leuven, Belgium.
Joeri MeynsOral & Maxillofacial Surgery, General Hospital St-Jan Genk, Genk, Belgium.ORCID 0000-0002-8702-6144
Nasser NadjmiDepartment of Cranio-Maxillofacial Surgery, University of Antwerp, Antwerp, Belgium.ORCID 0000-0002-0160-7256
Geert Van HemelenOral & Maxillofacial Surgery, ZMACK Association, AZ Monica Antwerp, Antwerp, Belgium.
Patrick WinderickxOral & Maxillofacial Surgery, ZMACK Association, AZ Monica Antwerp, Antwerp, Belgium.
Reinhilde JacobsOral and Maxillofacial Surgery-Imaging and Pathology Research Group, Department of Imaging and Pathology, University of Leuven and Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-3461-0363
Constantinus PolitisOral and Maxillofacial Surgery-Imaging and Pathology Research Group, Department of Imaging and Pathology, University of Leuven and Department of Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-4772-9897
Peter VerhammeDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-8698-2858
KU Leuven · BEZiekenhuisnetwerk Antwerpen Stuivenberg · BEKarolinska Institutet · SEUniversity of Antwerp · BEZiekenhuis Oost-Limburg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem. We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with NOACs. METHODS AND

findingsThe EXTRACT-NOAC study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients were randomly assigned to 10% TXA or placebo mouthwash and were instructed to use the mouthwash once prior to dental extraction, and thereafter for 3 times a day for 3 days. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes included periprocedural, early, and delayed bleeding, and the safety outcomes included all thrombotic events. The first patient was randomized on February 9, 2018 and the last patient on March 12, 2020. Of 222 randomized patients, 218 patients were included in the full analysis set, of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P = 0.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P = 0.07). TXA did not reduce the rate of periprocedural bleeding (bleeding score 4 ± 1.78 versus 4 ± 1.82, P = 0.80) and early bleeding (rate ratio, 0.76; 95% CI, 0.42 to 1.37). Delayed bleeding (rate ratio, 0.32; 95% CI, 0.12 to 0.89) and bleeding after multiple extractions (rate ratio, 0.40; 95% CI, 0.20 to 0.78) were lower in the TXA group. One patient in the placebo group had a transient ischemic attack while interrupting the NOAC therapy in preparation for the dental extraction. Two of the study limitations were the premature interruption of the trial following a futility analysis and the assessment of the patients' compliance that was based on self-reported information during follow-up.

conclusionsIn patients on NOACs undergoing dental extraction, TXA does not seem to reduce the rate of periprocedural or early postoperative oral bleeding compared to placebo. TXA appears to reduce delayed bleeds and postoperative oral bleeding if multiple teeth are extracted.

trial registrationClinicalTrials.gov NCT03413891 EudraCT; EudraCT number:2017-001426-17; EudraCT Public website: eudract.ema.europa.eu.

Indexed as

Administration, OralAgedAged, 80 and overAnticoagulantsAntifibrinolytic AgentsBelgiumDouble-Blind MethodFemaleHemorrhageHumansMaleMiddle AgedPostoperative HemorrhageProspective StudiesTooth ExtractionTranexamic AcidAnticoagulantsAntifibrinolytic AgentsTranexamic Acid

Identifiers

PMID33939696
PMCPMC8128271
OpenAlexW3159878030

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.