Ramström 1993.

Methods	Trial design: double‐blind RCT Follow up: 7 days
Participants	Countries: Denmark and Sweden Setting: oral surgery department of three hospitals: Karolinska Hospital and Huddinge Hospital in Stockholm, Sweden, and University Hospital in Aarhus, Denmark Inclusion criteria: Individuals on continuous, unchanged treatment with an oral anticoagulant (phenprocoumon, warfarin or dicoumarol) ‐ Older than 18 years ‐ Referred for tooth extraction (single or multiple), surgical removal of retained tooth (single or multiple), or endodontic surgery ‐ INR level within the therapeutic range (≥ 10% to ≤ 25%) Exclusion criteria: ‐ No informed consent ‐ Use of acetylsalicylic acid or nonsteroidal antiinflammatory agents within 14 days before surgery ‐ Indivduals known with haemorrhagic diathesis Sample size: TXA group: ‐ Total number of participant numbers: N = 44 ‐ Mean (range) number of extracted teeth: N = 1.5 (0 ‐ 5) ‐ Mean (range) number of surgically treated teeth: N = 1.6 (1 ‐ 5) Placebo group: ‐ Total number of participant numbers: N = 45 ‐ Mean (range) number of extracted teeth: N = 1.5 (0 ‐ 5) ‐ Mean (range) number of surgically treated teeth: N = 1.5 (1 ‐ 5) Numbers analysed/randomised: ‐ Safety analysis: N = 93/93 ‐ Main efficacy evaluation: N = 89/93 7 participants participated in the study 2 or 3 times. The 93 participants included in the safety analysis represented 86 individuals, and the 89 participants included in the efficacy evaluation represented 82 individuals. 4 participants were excluded from the main efficacy analysis, 2 because of incorrect inclusion (1 on an anti‐inflammatory agent and 1 subjected to an inappropriate type of surgery), and 2 because the first treatment period was not finished before the participant was included in a second Participant characteristics: ‐ Age in years, mean (range): TXA group: 69.8 (53 ‐ 87), placebo group: 67.1 (35 ‐ 83) ‐ Sex N (M/F): 53/36 ‐ INR: 2.10 ‐ 4.00
Interventions	Intervention group: Before suturing: irrigation with 10 mL 4.8% TXA solution Postoperatively: rinsing with 10 mL TXA mouthwash for 2 min 4x daily for 7 days Control group: Before suturing: irrigation with 10 mL placebo solution Postoperatively: placebo mouthwash for 2 min 4x daily for 7 days
Outcomes	1. Number of postoperative bleeding episodes requiring intervention 2. Side effects or other adverse events 3. Number of minor postoperative bleeding episodes (defined as self‐limiting, usually with local pressure, that does not require medical attention) 4. Any postoperative complication except bleeding, such as wound infection 5. Major bleeding, requiring transfusion of packed red blood cells Bleeding was defined as postoperative bleeding that could not be controlled by compression with a gauze pad for 20 min, with the participant sitting upright
Notes	All intervention and control groups were eligible for the review
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"patients who met the inclusion criteria were randomised to either the tranexamic acid or placebo Group by the use of consecutively numbered medication packages." (Materials and Methods, page 1212)
Allocation concealment (selection bias)	Low risk	"A written patient information sheet and a sealed envelope with information about the randomisation code for each patient, to be opened in case of emergency, were prepared by Kabi Pharmacia." (Materials and Methods, page 1212)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The investigation was a randomised, double‐blind, placebo‐controlled, multicenter study." (Abstract, page 1211) "Active solution, 10 mL, containing 4.8% tranexamic acid and an apparently identical placebo solution, also produced by Kabi Pharmacia, were used." (Materials and Methods, page 1212)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	This is not clearly discussed in the article
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up: the results of all participants are reported. Reasons for excluding 4 participants from the main efficacy analysis after randomisation are also included in the results section (Results, page 1213‐5)
Selective reporting (reporting bias)	Low risk	All pre‐specified outcome measures are reported for all trial participants
Other bias	Low risk	Multiple randomisations: "Seven participants participated in the study two or three times." (Results, page 1213). Considered as low risk of bias, as participants were blinded