Cochrane · intervention · CD012293
Antifibrinolytic therapy for preventing oral bleeding in people on anticoagulants undergoing minor oral surgery or dental extractions
Engelen, ET, Schutgens, REG, Mauser‐Bunschoten, EP, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library
Cystic Fibrosis and Genetic DisordersOral HealthOral and maxillofacial surgery2 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
13
current version
GRADE rated
3
No studies
5
Included studies
4
as reported
No studies 5 · 38.5%Ungraded 5 · 38.5%Very low 0 · 0%Low 0 · 0%Moderate 3 · 23.1%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | People of all ages on continuous VKA or DOAC treatment undergoing oral or dental procedures (therapeutic INR 2.0 to 4.0; people using acetylsalicylic acid excluded) | People on continuous VKA treatment undergoing dental extractions/minor oral surgery (n=253 analysed; mean age 60; INR within therapeutic range); no eligible DOAC studies (n=0) |
| Intervention | Antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)) at any dose, route (topical, oral or intravenous), frequency or duration; started before, during or after the procedure | Locally-applied tranexamic acid (TXA) mouthwash/solution (n=4 trials); no EACA and no systemic TXA identified (n=0) |
| Comparison | Placebo; No intervention; Usual care with or without placebo (usual care mainly surgical intraoperative measures e.g. mucosal flap, gauze compression, sutures; comparators receiving additional haemostatic agents excluded) | Placebo solution/mouthwash (n=2 trials, 128 participants); Standard care - gelatin sponge and sutures, or dry gauze compression (n=2 trials, 125 participants) |
| Outcomes | Number of participants with major postoperative bleeding episodes (requiring intervention); Side effects or other adverse events; Number of minor postoperative bleeding episodes; Number of immediate and delayed postoperative bleeding episodes requiring intervention; Any postoperative complication except bleeding; Change in haemoglobin level from baseline; Major bleeding requiring transfusion of packed red blood cells; Bleeding duration (minutes); Amount of postoperative blood loss (mL); Number of thromboembolic complications | Postoperative bleedings requiring intervention (n=4 trials, 253); Side effects/adverse events requiring withdrawal (n=2, 128); Minor postoperative bleeding (n=2, 128); Immediate and delayed postoperative bleeding (n=1, 89); Complications other than bleeding (n=2, 128); Major bleeding requiring transfusion (n=4, 253) |
| Study designs | RCTs or quasi-RCTs | 3 RCTs; 1 quasi-RCT (n=4) |
| Timing | Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | 7 days follow-up (n=4) |
Search date: 2018-02. Databases: Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); Cochrane Database of Systematic Reviews (CDSR); MEDLINE; PubMed; Embase; CINAHL; PQDT Open (ProQuest Dissertations); ClinicalTrials.gov; WHO International…
Questions and results
Current version onlyAntifibrinolytic therapy - locally-applied tranexamic acid (TXA) mouthwash/solution (SoF eligibility: TXA or EACA; all included trials used topical TXA) vs Placebo (placebo solution/mouthwash)
Population: People on continuous VKA treatment undergoing minor oral surgery or dental extractions (eligibility included DOACs and all ages; all four included trials were adults on VKAs with INR within the therapeutic range, mean age 60 years)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of minor postoperative bleeding episodes 7 days | RD -0.06 [-0.33, 0.20] | 2 studies · 128 participants | Ungraded |
Side effects or other adverse events requiring withdrawal 7 days | RD 0.00 [-0.04, 0.04] No adverse events requiring withdrawal occurred in the placebo group vs No adverse events requiring withdrawal… | 2 studies · 128 participants | Moderate Downgraded: imprecision |
Change in haemoglobin level from baseline | no estimate extracted | 0 studies | No studies |
Number of thromboembolic complications | no estimate extracted | 0 studies | No studies |
Bleeding duration (minutes, all types of bleeding, minor and major) | no estimate extracted | 0 studies | No studies |
Major bleeding requiring transfusion of packed red blood cells 7 days | RD -0.00 [-0.05, 0.04] | 2 studies · 128 participants | Ungraded |
Number of immediate and delayed postoperative bleeding episodes requiring intervention Immediate (<24 h) and delayed (24 h to 10 days); bleeds occurred 1, 3 or 5 days postoperatively | RD -0.22 [-0.35, -0.10] | 1 study · 89 participants | Ungraded |
Any postoperative complication except bleeding (e.g. wound infection) 7 days | RD -0.02 [-0.07, 0.03] | 2 studies · 128 participants | Ungraded |
Number of participants with postoperative bleedings requiring intervention 7 days | RD -0.25 [-0.36, -0.14] -69 [-100, -4] per 1000 | 2 studies · 128 participants | Moderate Downgraded: imprecision |
Amount of postoperative blood loss (mL) | no estimate extracted | 0 studies | No studies |
Antifibrinolytic therapy - locally-applied tranexamic acid (TXA) mouthwash/solution (SoF eligibility: TXA or EACA; all included trials used topical TXA) vs Standard care (usual local haemostatic measures: gelatin sponge and sutures, or dry gauze compression)
Population: People on continuous VKA treatment undergoing minor oral surgery or dental extractions (eligibility included DOACs and all ages; all four included trials were adults on VKAs with INR within the therapeutic range, mean age 60 years)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of participants with postoperative bleedings requiring intervention 7 days | RD 0.02 [-0.07, 0.11] 1 [-4, 7] per 10,000 | 2 studies · 125 participants | Moderate Downgraded: imprecision |
Major bleeding requiring transfusion of packed red blood cells 7 days | RD 0.00 [-0.04, 0.04] | 2 studies · 125 participants | Ungraded |
Antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)) vs Placebo, no intervention, or usual care
Population: People on continuous direct oral anticoagulant (DOAC) treatment undergoing oral or dental procedures
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | no estimate extracted | 0 studies | No studies |
Antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)) at any dose, route (topical, oral or intravenous), frequency or duration; started before, during or after the procedure vs Placebo, or no intervention, or usual care with or without placebo
Population: People of all ages on VKA or DOAC treatment undergoing oral or dental procedures (therapeutic INR 2.0 to 4.0; people using acetylsalicylic acid excluded)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side effects or other adverse events Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Number of thromboembolic complications Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Any postoperative complication except bleeding (e.g. wound infection) Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Number of minor postoperative bleeding episodes Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Number of immediate and delayed postoperative bleeding episodes requiring intervention Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Amount of postoperative blood loss (mL) Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Number of major postoperative bleeding episodes (requiring intervention) Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Change in haemoglobin level from baseline Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Major bleeding, requiring transfusion of packed red blood cells Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |
Bleeding duration (minutes, all types of bleeding, minor and major) Postoperative up to 10 days (immediate <24 h; delayed 24 h to 10 days) | no estimate extracted | 0 studies | No studies |