Detailed study characteristics, risk-of-bias tables, subgroup results

From 152 records screened, 19 studies were included: three cohort studies (170 patients) and 16 case reports/small series.Cohort studies:Standardized bivalirudin protocols (bolus 1.0–1.2 mg/kg, infusion 2.0–2.7 mg/kg/h, ACT ≈480 s) were effective.Major bleeding: pooled incidence 10.6% (95% CI: 6.4–16.9%).Thromboembolic events: pooled incidence 2.1% (95% CI: 0.4–4.8%).Early mortality: ≤3%.No CPB circuit thrombosis or oxygenator exchanges were required.Around 14% of patients needed dose adjustments due to ACT variability.Case reports/series:Showed feasibility in high-risk settings (emergent surgery, transplantation, pediatrics, renal failure, redo sternotomy).ACT-guided protocols maintained circuit integrity, with no perioperative deaths or circuit failures.Some cases required modified monitoring (e.g., plasma-modified ACT in thrombocytopenia, dose reduction in pediatrics).Secondary outcomes:Reoperation for bleeding: 5.3%.Transfusion needs were variable but not excessive.ICU stay: 2–4 days; hospital stay: 7–10 days.No ECMO or mechanical circulatory support was required.本研究初筛共获取152条记录，最终纳入19项研究：包含3项队列研究（共计170例患者）与16篇病例报告/小样本病例系列研究。 队列研究：标准化比伐卢定（bivalirudin）给药方案（弹丸注射剂量1.0~1.2 mg/kg，持续输注剂量2.0~2.7 mg/kg/h，活化凝血时间（activated clotting time，ACT）≈480 s）疗效可靠。大出血事件的合并发生率为10.6%（95%置信区间CI：6.4~16.9%）；血栓栓塞事件的合并发生率为2.1%（95% CI：0.4~4.8%）；早期死亡率≤3%。未出现体外循环（cardiopulmonary bypass，CPB）管路血栓形成或氧合器更换情况。约14%的患者因活化凝血时间波动需调整给药剂量。 病例报告/小样本系列研究：该方案在高危场景（急诊手术、器官移植、儿科患者、肾功能衰竭、再次胸骨切开术）中展现出临床可行性。以活化凝血时间为指导的给药方案可维持管路完整性，未发生围手术期死亡或管路故障。部分病例需调整监测方案（例如针对血小板减少症患者采用血浆修正活化凝血时间监测、儿科患者需减量给药）。 次要结局指标：因出血再次手术率为5.3%；输血需求存在个体差异但未达过量水平；重症监护病房（intensive care unit，ICU）停留时长为2~4天，住院时长为7~10天；未使用体外膜肺氧合（extracorporeal membrane oxygenation，ECMO）或机械循环支持设备。