预防性纤维蛋白原浓缩物在小儿颅缝早闭手术矫正中的应用：一项双盲安慰剂对照试验。

Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A double-blind placebo-controlled trial.

机构信息

From the Department of Paediatric Anaesthesiology (AM), Department of Paediatric Haematology, Erasmus University Medical Centre - Sophia Children's Hospital, Rotterdam (EJH, IMA, SEL, MHC, CHvO) and Department of Biometrics, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands (ML-Y).

出版信息

Eur J Anaesthesiol. 2021 Sep 1;38(9):908-915. doi: 10.1097/EJA.0000000000001332.

DOI:10.1097/EJA.0000000000001332

PMID:33009187

Abstract

BACKGROUND

Surgical craniosynostosis repair in children is associated with massive blood loss and significant transfusion of blood products. Fibrinogen concentrate is claimed to be useful in reducing blood loss and transfusion requirements.

OBJECTIVE

We investigated whether prophylactic administration of fibrinogen concentrate will reduce blood loss and transfusion requirements during paediatric craniofacial surgery.

DESIGN

Randomised, placebo-controlled, double-blind clinical trial.

SETTING

University medical centre.

PATIENTS

A total of 114 infants and children up to 25 months of age (median age 10 months).

INTERVENTION

Surgical craniosynostosis repair by calvarial remodelling was performed in each patient. Patients were randomised to receive prophylactic fibrinogen concentrate (Haemocomplettan P) at a mean dose of 79 mg kg-1 body weight or placebo.

MAIN OUTCOME MEASURES

Primary outcome was the volume of transfused blood products. Secondary outcomes were peri-operative blood loss, duration of surgery, length of stay in the paediatric ICU, length of hospital stay, postoperative complications and adverse effects of fibrinogen concentrate infusion.

RESULTS

No significant differences (P < 0.05) were found in the volume of transfused blood products (median 29 ml kg-1 body weight vs. 29 ml kg-1 body weight), intra-operative estimated blood loss (45 vs. 46 ml kg-1), calculated blood loss (57 vs. 53 ml kg-1), or postoperative blood loss (24 vs. 24 ml kg-1) between the intervention and placebo groups. In addition, duration of surgery, length of stay in the paediatric ICU, hospital stay and complications were not significantly different between the two groups.

CONCLUSION

During surgical craniosynostosis repair in young children, prophylactic administration of high-dose fibrinogen concentrate did not reduce the amount of transfused blood products or decrease peri-operative blood loss.

TRIAL REGISTRATION

National Trial Register (NTR2975) and EudraCT (2011-002287-24).

摘要

背景

儿童颅缝早闭修复术会导致大量失血和大量输血。纤维蛋白原浓缩物据称可减少失血和输血需求。

目的

我们研究了预防性给予纤维蛋白原浓缩物是否会减少小儿颅面外科手术中的失血和输血需求。

设计

随机、安慰剂对照、双盲临床试验。

地点

大学医学中心。

患者

共纳入 114 名 25 个月以下的婴儿和儿童（中位年龄 10 个月）。

干预措施

每位患者均行颅骨重塑术治疗颅缝早闭。患者被随机分为预防性纤维蛋白原浓缩物（Haemocomplettan P）组，平均剂量为 79mg/kg 体重，或安慰剂组。

主要观察指标

主要结局是输注的血液制品量。次要结局是围手术期失血、手术持续时间、儿科重症监护病房住院时间、住院时间、术后并发症和纤维蛋白原浓缩物输注的不良反应。

结果

两组间输注的血液制品量（中位数 29ml/kg 体重比 29ml/kg 体重）、术中估计失血（45ml/kg 体重比 46ml/kg 体重）、计算失血（57ml/kg 体重比 53ml/kg 体重）或术后失血（24ml/kg 体重比 24ml/kg 体重）均无显著差异（P＞0.05）。此外，两组间手术持续时间、儿科重症监护病房住院时间、住院时间和并发症也无显著差异。