Prophylactic Hemostatic Treatment to Control Iatrogenic Bleeding During Endobronchial Biopsy (PROTECT Study): A Multicenter, Randomized, Single-Anonymized, Placebo-Controlled Study.

Although some guidelines and studies recommend the prophylactic use of hemostatic agents, there is still insufficient evidence from clinical studies.

尽管一些指南和研究推荐预防性使用止血剂，但来自临床研究的证据仍然不足。

research_question

Is prophylactic hemostatic treatment effective for controlling bleeding in patients undergoing endobronchial biopsy?

预防性止血治疗对于控制接受支气管内活检患者出血是否有效？

study_design_and_methods

In this multicenter, randomized, placebo-controlledtrial, eligible participants scheduled to undergo endobronchial biopsy were randomly assigned (1:1:1) to the adrenaline group, the ice-cold saline group, or the saline (placebo) group.

在这项多中心、随机、安慰剂对照试验中，计划接受支气管内活检的合格参与者被随机分配（1:1:1）到肾上腺素组、冰冷盐水组或盐水（安慰剂）组。

The primary efficacy outcomes were defined as the Bleeding Severity Scale and the visual analog scale in the termination of the biopsy.

主要疗效结果被定义为出血严重程度量表和视觉模拟量表在活检结束时。

Results

A total of 462 participants were randomly assigned to the 3 groups and assessed for efficacy and safety outcomes.

共有462名参与者被随机分配到3个组别，并对疗效和安全性结果进行了评估。

Overall, prophylactic hemostasis did not statistically improve the bleeding condition based on the Bleeding Severity Scale or the visual analog scale.

总体而言，预防性止血并未在出血严重程度量表或视觉模拟量表基础上统计学上显著改善出血状况。

However, in the subgroup of patients < 65 years of age, the incidenceof bleeding in the ice-cold saline group showed a decreasing trend compared with the placebo group (relative risk, 0.90; 95% CI, 0.82-0.99; P = .04).

然而，在年龄小于65岁的患者亚组中，冰盐水组的出血发生率与安慰剂组相比显示出下降趋势（相对风险，0.90；95%置信区间，0.82-0.99；P = .04）。

Besides, our findings demonstrated the safety of prophylactic hemostasis.

此外，我们的研究结果表明预防性止血是安全的。

interpretation

We did not observe any improvement in biopsy-related iatrogenic bleeding with the prophylactic hemostasis.

我们没有观察到预防性止血对活检相关的医源性出血有任何改善。

However, we observed a trend toward reduced bleeding with prophylactic hemostasis in the subgroup of patients < 65 years of age, which merits further study.

然而，我们在年龄小于65岁的患者亚组中观察到预防性止血减少出血的趋势，这值得进一步研究。

clinical_trial_registration

Chinese Clinical Trial Register; No.: ChiCTR2400089591; URL: https://www.chictr.org.cn/indexEN.html.

中国临床试验注册中心；编号：ChiCTR2400089591；网址：https://www.chictr.org.cn/indexEN.html。