{
  "abstract": "Purpose\n\nNeonatal 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\n\nIn 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\n\nMean 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\n\nAn 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\n\nChiCTR2300069157.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.",
    "Department 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.",
    "Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.",
    "Department of Anesthesiology, The Second Affiliated Hospital of Hainan Medical University, Haikou, People's Republic of China.",
    "Center 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."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 10,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "He Wang"
    },
    {
      "affs": [
        1
      ],
      "name": "Qindong Liu"
    },
    {
      "affs": [
        2
      ],
      "name": "Peng Gao"
    },
    {
      "affs": [
        1
      ],
      "name": "Jia Liu"
    },
    {
      "affs": [
        1
      ],
      "name": "Yu Jin"
    },
    {
      "affs": [
        1
      ],
      "name": "Tianyu Gao"
    },
    {
      "affs": [
        3
      ],
      "name": "Wenting Wang"
    },
    {
      "affs": [
        4
      ],
      "name": "Dabuxilite Bayartaikishigtai"
    },
    {
      "affs": [
        4
      ],
      "name": "Yang Zhang"
    },
    {
      "affs": [
        1
      ],
      "name": "Jinping Liu"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/ba83njx29q8j5.bib",
  "cited_by": 0,
  "doi": "10.2147/dddt.s634756",
  "fulltext_url": "https://europepmc.org/articles/PMC13679529",
  "id": "ba83njx29q8j5",
  "issns": [
    "1177-8881"
  ],
  "landing_url": "https://europepmc.org/article/MED/42899169",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2746|Cardiac and Coronary Surgery Techniques"
    ]
  ],
  "openalex": "W7221823248",
  "pdf_url": "https://europepmc.org/articles/PMC13679529?pdf=render",
  "pmcid": "PMC13679529",
  "pmid": "42899169",
  "published": "2026-10-15",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/ba83njx29q8j5.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:33Z",
      "native_id": "MED:42899169",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42899169"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2746|Cardiac and Coronary Surgery Techniques",
      "subfield": "surgery"
    }
  ],
  "title": "Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial.",
  "title_text": "Optimization of Anticoagulation Strategy During Cardiopulmonary Bypass in Neonates with Congenital Heart Disease: A Randomized Controlled Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:33Z",
  "url": "https://research.draconitic.com/paper/ba83njx29q8j5",
  "venue": "Drug design, development and therapy",
  "versions": []
}