Summary of findings of RCTs that compared increasing VWF levels to 0.50 IU/mL alone vs increasing VWF levels to 0.50 IU/mL and prescribing TXA for patients with VWD undergoing minor surgery
| Outcomes . | No. of participants . | No. of follow-up RCTs . | Certainty of the evidence . | GRADE . | RR (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|---|---|
| Risk with increasing VWF to 0.50 IU/mL + TXA . | Difference in risk with increasing VWF level to 0.50 IU/mL . | ||||||
| Postoperative bleeding | 59 | 2 | ⨁◯◯◯ | Very low*†‡ | 6.29 (2.12-18.65) | 103/1000 | 547 more per 1000 (116-1826 more) |
| AEs requiring withdrawal | 59 | 2 | ⨁⨁◯◯ | Low*‡ | Not estimable | 34/1000 | 34 fewer per 1000 (34-34 fewer) |
| Major bleeding requiring transfusion | 31 | 1 | ⨁⨁◯◯ | Low*† | Not estimable | 0/1000 | 0 fewer per 1000 (0-0 fewer) |
| Postoperative blood loss, mL § | 28 | 1 | ⨁◯◯◯ | Very low*†ǁ | |||
| Outcomes . | No. of participants . | No. of follow-up RCTs . | Certainty of the evidence . | GRADE . | RR (95% CI) . | Anticipated absolute effects . | |
|---|---|---|---|---|---|---|---|
| Risk with increasing VWF to 0.50 IU/mL + TXA . | Difference in risk with increasing VWF level to 0.50 IU/mL . | ||||||
| Postoperative bleeding | 59 | 2 | ⨁◯◯◯ | Very low*†‡ | 6.29 (2.12-18.65) | 103/1000 | 547 more per 1000 (116-1826 more) |
| AEs requiring withdrawal | 59 | 2 | ⨁⨁◯◯ | Low*‡ | Not estimable | 34/1000 | 34 fewer per 1000 (34-34 fewer) |
| Major bleeding requiring transfusion | 31 | 1 | ⨁⨁◯◯ | Low*† | Not estimable | 0/1000 | 0 fewer per 1000 (0-0 fewer) |
| Postoperative blood loss, mL § | 28 | 1 | ⨁◯◯◯ | Very low*†ǁ | |||
The following outcomes were not reported: serious AEs, mortality, need for additional hemostatic agents, need for additional surgical procedures, and inability to perform the surgery. The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). GRADE Working Group grades of evidence: Low certainty: Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the estimate of effect. The true effect is likely to be substantially different from the estimate of effect.
RR, risk ratio.
Randomization and allocation concealment were at unclear or high risk of bias in both trials.
The panel judged that there were serious applicability concerns because all the patients had hemophilia.
Small number of patients and events overall and very wide CIs.
Increasing FVIII level to 0.50 IU/mL: mean blood loss per participant, 84.1 mL (range, 4-323 mL) (n = 14). Increasing FVIII level to 0.50 IU/mL + TXA: mean blood loss per participant, 61.2 mL (range, 1-749 mL) (n = 14). P = .02.
Meta-analysis was performed in Risk Difference (RD) because there were no AEs in either arm in 1 trial.