Cochrane · intervention · CD011385
Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions
van Galen, KPM, Engelen, ET, Mauser‐Bunschoten, EP, et al. · Cochrane Database of Systematic Reviews · 2019 · Cochrane Library
Cystic Fibrosis and Genetic DisordersOral HealthOral and maxillofacial surgery3 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
11
current version
GRADE rated
2
No studies
5
Included studies
2
as reported
No studies 5 · 45.5%Ungraded 4 · 36.4%Very low 0 · 0%Low 1 · 9.1%Moderate 1 · 9.1%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 with haemophilia or VWD undergoing any type of oral or dental procedures. VWD defined as VWF activity less than 40% and haemophilia A or B as FVIII or FIX levels less than 40%. Minor oral surgery defined as dentoalveolar surgery such as third molar removal, dental implant placement and periodontal surgery. | 59 males with haemophilia A or B aged 12 to 65 years undergoing dental extractions (no VWD participants). Forbes 1972: 28 participants, FVIII/IX 0% to 23% of normal, aged 13 to 65 years. Walsh 1971: 31 participants, factor VIII or IX levels 15% or less, aged 12 years or older. |
| Intervention | Use of the antifibrinolytic agents (TXA or EACA) to prevent perioperative bleeding at any dose, mode of delivery (topical, oral or intravenous), frequency and duration of administration, whether started before, during or immediately after the intervention. | Tranexamic acid, oral (Forbes 1972) (n=14); Epsilon aminocaproic acid, IV then oral (Walsh 1971) (n=15) |
| Comparison | Placebo or no intervention or usual care, with or without placebo. Usual care includes local haemostatic measures (except local antifibrinolytic agents) and prophylactic factor replacement therapy. | Placebo (Forbes 1972 n=14; Walsh 1971 n=16) (n=30) |
| Outcomes | Primary: Number of postoperative bleeding episodes requiring intervention; Side effects or other adverse events. Secondary: 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; Amount of postoperative blood loss; Need for and dose of clotting factor concentrates | Number of postoperative bleeding episodes requiring intervention (n=59); Side effects or other adverse events (n=59); Change in haemoglobin level from baseline (n=59); Amount of postoperative blood loss (n=28); Need for and dose of clotting factor concentrates (n=59); Major bleeding requiring transfusion of packed red blood cells (n=31) |
| Study designs | Randomised and quasi-randomised controlled trials | Randomised controlled trial (n=1); Quasi-randomised controlled trial (n=1) |
| Timing | Up to 10 days after surgery (immediate <24 h; delayed 24 h to 10 days) | Forbes 1972: 5 days follow-up; Walsh 1971: 7 to 10 days follow-up |
Search date: 2019-03. Databases: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Haemophilia journal (handsearch); European Haematology Association conference; American Society of Hematology conference; International Society on Thrombosis and Haemostasis (ISTH) abstracts; Congress of the World Federation of…
Questions and results
Show all 3 versionsAntifibrinolytic therapy (tranexamic acid or epsilon aminocaproic acid) vs Placebo, no intervention or usual care (with or without placebo)
Population: People with haemophilia (A or B) undergoing minor oral surgery or dental extractions
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of minor postoperative bleeding episodes | This outcome was not reported in either of the trials. | 0 studies | No studies |
Bleeding duration | This outcome was not reported in either of the trials. | 0 studies | No studies |
Any postoperative complication except bleeding (such as wound infection) | This outcome was not reported in either of the trials. | 0 studies | No studies |
Number of postoperative bleeding episodes requiring intervention Up to 10 days postoperative | RD -0.57 [-0.76, -0.37] -57 [-76, -36] per 100 | 2 studies · 59 participants | Moderate Downgraded: imprecision, inconsistency |
Need for and dose of clotting factor concentrates | Reported in both trials in different ways. Forbes (TXA): mean units of replacement therapy per root extracted 617 IU (range 0 to 15,800) in 11 placebo participants versus 30 IU and 65 IU per root in 2 TXA participants… | 2 studies · 59 participants | Ungraded |
Amount of postoperative blood loss (mL) | Only reported in the Forbes (TXA) trial: over five-day follow-up, mean blood loss per participant 84.1 mL (range 4 to 323) in the placebo group (n=14) versus 61.2 mL (range 1 to 749) in the TXA group (n=14), P = 0.02. | 1 study · 28 participants | Ungraded |
Major bleeding, requiring transfusion of packed red blood cells | Only reported in the Walsh (EACA) trial: in none of the 31 included participants was blood transfusion required. | 1 study · 31 participants | Ungraded |
Change in haemoglobin level from baseline | Mean fall in haemoglobin. Forbes (TXA): 1.4 g/100 mL (placebo) vs 0.3 g/100 mL (TXA). Walsh (EACA): 6.3% (placebo, both centres) vs 3.9% and 3.7% (EACA, centres 1 and 2); differences not significant. Reported in… | 2 studies · 59 participants | Ungraded |
Number of immediate (less than 24 hours) and delayed (24 hours to 10 days) postoperative bleeding episodes requiring intervention Immediate (<24 h) and delayed (24 h to 10 days) | This outcome was not reported in either of the trials. | 0 studies | No studies |
Side effects or other adverse events Up to 10 days postoperative | RD 0.034 [-0.32, 0.38] 3.4 [-32, 38] per 100 | 2 studies · 59 participants | Low Downgraded: imprecision, inconsistency |
Antifibrinolytic therapy (tranexamic acid or epsilon aminocaproic acid) vs Placebo, no intervention or usual care (with or without placebo)
Population: People with Von Willebrand disease undergoing minor oral surgery or dental extractions
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No randomised or quasi-randomised controlled trials in people with Von Willebrand disease met the inclusion criteria; no eligible VWD trials were identified. | 0 studies | No studies |