Impact of tranexamic acid on postpartum hemorrhage in type 1 von Willebrand disease treated with recombinant VWF.

Because tranexamic acid (TXA) reduced PPH-related deaths in the WOMAN trial, we assessed whether TXA combined with rVWF vs rVWF alone prevents PPH in VWD.

因为在WOMAN试验中，氨甲环酸（TXA）减少了与PPH相关的死亡，我们评估了TXA与rVWF联合使用与仅使用rVWF相比，是否能预防VWD患者的PPH。

VWD-Woman, a phase 3, open-label, randomized pilot trial, enrolled pregnant women with VWD, aged ≥18 years (von Willebrand Factor Ristocetin Cofactor activity [VWF:RCo] of <0.50 IU/mL, bleeding history).

VWD-Woman是一项3期、开放标签、随机初步试验，招募了年龄≥18岁的VWD孕妇（von Willebrand因子Ristocetin辅因子活性[VWF:RCo] <0.50 IU/mL，有出血史）。

Participants received IV rVWF 80 IU/kg at delivery and postpartum days 1 and 2, with or without TXA (1 g within 3 hours of delivery).

参与者在分娩时以及产后第1天和第2天接受了80 IU/kg的静脉注射rVWF治疗，可选择性地与TXA联合使用（分娩后3小时内使用1 g TXA）。

The primary outcome was quantitative blood loss (QBL) at delivery.

主要结果是分娩时的定量失血量（QBL）

Secondary outcomes included 21-day pictorial blood assessment chart (PBAC) scores, hemoglobin changes, transfusions, hysterectomy, and safety.

次要结果包括21天的图像式血评估图（PBAC）评分、血红蛋白变化、输血、子宫切除术和安全性。

Of 103 screened, 40 were eligible, and 20 enrolled (10 per group), 100% were iron-deficient.

在103名筛查对象中，有40人符合资格，其中20人（每组10人）参与了研究，所有参与者均存在铁缺乏。

Mean QBL was similar (TXA + rVWF: 727.0 mL; 95% CI, 434.5-1019.5] vs rVWF: 539.7 mL [95% CI, 132.8-946.6]; P = 0.41), as were rates of PPH (30% in both groups).

平均失血量相似（TXA + rVWF组：727.0毫升；95%置信区间，434.5-1019.5毫升 vs rVWF组：539.7毫升；95%置信区间，132.8-946.6毫升；P = 0.41），两组的产后出血（PPH）发生率也相同（均为30%）。

No differences were observed in hemoglobin change (-1.90 g/dL vs -1.42 g/dL, P = 0.49) or 21-day PBAC score (467.1 vs 344.8, P = 0.32).

观察到血红蛋白变化（-1.90 g/dL 对比 -1.42 g/dL, P = 0.49）或21天PBAC评分（467.1 对比 344.8, P = 0.32）之间无差异。

Stratified analyses showed no differences by age, body mass index, VWF activity, or delivery type.

分层分析显示，按年龄、体重指数、VWF活性或分娩类型分组后，未见差异。

No serious adverse events or thrombosis occurred.

未发生严重不良事件或血栓形成。

TXA plus rVWF is feasible and safe in type 1 VWD, but in this small pilot study, was not associated with a reduction in PPH compared with rVWF alone.

在1型VWD患者中，使用TXA联合rVWF是可行且安全的，但在本小型初步研究中，与单独使用rVWF相比，并未显示出减少产后出血（PPH）的效果。

Iron deficiency is prevalent.

铁缺乏症普遍存在。

Further studies are needed to improve PPH prevention in VWD.

需要进一步的研究来改善VWD中PPH的预防。

This trial was registered at www.ClinicalTrials.gov as #NCT04344860.

这项试验已在www.ClinicalTrials.gov上注册，注册号为#NCT04344860。