Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial.
5 affiliations
- 1Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.
- 2Department of Cardiopulmonary Bypass, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
- 3Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
- 4Department of Anesthesiology, The Second Affiliated Hospital of Hainan Medical University, Haikou, People's Republic of China.
- 5Center of Laboratory Medicine, Beijing Key Laboratory of Cardiovascular Disease Warning and Diagnosis, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Abstract
Purpose
Neonatal hemostatic immaturity complicates anticoagulation during cardiopulmonary bypass (CPB). Current practice largely follows the strategy of 400 U/kg from adult protocols, as neonatal-specific guidelines and high-quality evidence remain lacking, which frequently fails to achieve adequate anticoagulation. This single-center randomized controlled trial evaluated the initial heparin dose of 600 U/kg to refine neonatal CPB anticoagulation.Patients and methods
In this prospective, randomized, controlled, single-blind trial, 76 neonates undergoing CPB were assigned to receive an initial heparin dose of either 600 U/kg (n = 38) or 400 U/kg (n = 38). The primary endpoint was the pre- to post-CPB change in prothrombin fragment 1+2 (ΔF1+2). Secondary endpoints included the proportion of neonates achieving the ACT threshold after the initial heparin bolus, perioperative coagulation measures, postoperative blood loss, transfusion requirements, and adverse clinical outcomes.Results
Mean ΔF1+2 was 0.70 vs 4.08 nmol/L in the 600 and 400 U/kg groups, respectively (treatment-minus-control mean difference, -3.38 nmol/L; 95% confidence interval, -4.58 to -2.18; P <0.001). ACT target achievement rate after the initial dose was higher in the 600 U/kg group (84.2% vs 44.7%, P < 0.001). Surgical preparation time was shorter (median 31.50 vs 36.50 mins, P = 0.028), and supplemental heparin use was lower, while total heparin dose did not differ significantly. Secondary endpoints showed lower 72-hour chest drainage and albumin use and shorter mechanical ventilation duration (P = 0.036, 0.028, and 0.031, respectively). Red-cell, plasma, and platelet transfusion requirements and most other clinical outcomes did not differ significantly. One in-hospital death occurred with 600 U/kg and none with 400 U/kg. Complete-case sensitivity analysis supported the primary finding.Conclusion
An initial heparin dose of 600 U/kg in neonatal CPB was associated with a smaller F1+2 increase and greater initial ACT response. Larger studies are needed to establish clinical benefit and safety.Clinical trial registry number
ChiCTR2300069157.
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BibTeX
@article{wang2026optimization,
title = {{Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial.}},
author = {He Wang and Qindong Liu and Peng Gao and Jia Liu and Yu Jin and Tianyu Gao and Wenting Wang and Dabuxilite Bayartaikishigtai and Yang Zhang and Jinping Liu},
journal = {Drug design, development and therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s634756},
url = {https://europepmc.org/article/MED/42899169},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial.
AU - He Wang
AU - Qindong Liu
AU - Peng Gao
AU - Jia Liu
AU - Yu Jin
AU - Tianyu Gao
AU - Wenting Wang
AU - Dabuxilite Bayartaikishigtai
AU - Yang Zhang
AU - Jinping Liu
PY - 2026
DA - 2026/10/15
JO - Drug design, development and therapy
DO - 10.2147/dddt.s634756
UR - https://europepmc.org/article/MED/42899169
AB - Purpose Neonatal hemostatic immaturity complicates anticoagulation during cardiopulmonary bypass (CPB). Current practice largely follows the strategy of 400 U/kg from adult protocols, as neonatal-specific guidelines and high-quality evidence remain lacking, which frequently fails to achieve adequate anticoagulation. This single-center randomized controlled trial evaluated the initial heparin dose of 600 U/kg to refine neonatal CPB anticoagulation.Patients and methods In this prospective, randomized, controlled, single-blind trial, 76 neonates undergoing CPB were assigned to receive an initial heparin dose of either 600 U/kg (n = 38) or 400 U/kg (n = 38). The primary endpoint was the pre- to post-CPB change in prothrombin fragment 1+2 (ΔF1+2). Secondary endpoints included the proportion of neonates achieving the ACT threshold after the initial heparin bolus, perioperative coagulation measures, postoperative blood loss, transfusion requirements, and adverse clinical outcomes.Results Mean ΔF1+2 was 0.70 vs 4.08 nmol/L in the 600 and 400 U/kg groups, respectively (treatment-minus-control mean difference, -3.38 nmol/L; 95% confidence interval, -4.58 to -2.18; P <0.001). ACT target achievement rate after the initial dose was higher in the 600 U/kg group (84.2% vs 44.7%, P < 0.001). Surgical preparation time was shorter (median 31.50 vs 36.50 mins, P = 0.028), and supplemental heparin use was lower, while total heparin dose did not differ significantly. Secondary endpoints showed lower 72-hour chest drainage and albumin use and shorter mechanical ventilation duration (P = 0.036, 0.028, and 0.031, respectively). Red-cell, plasma, and platelet transfusion requirements and most other clinical outcomes did not differ significantly. One in-hospital death occurred with 600 U/kg and none with 400 U/kg. Complete-case sensitivity analysis supported the primary finding.Conclusion An initial heparin dose of 600 U/kg in neonatal CPB was associated with a smaller F1+2 increase and greater initial ACT response. Larger studies are needed to establish clinical benefit and safety.Clinical trial registry number ChiCTR2300069157.
SN - 1177-8881
ER -