PRISMA Flow Diagram

This study is a systematic review and meta-analysis evaluating the safety and efficacy of bivalirudin as an anticoagulant in patients with heparin-induced thrombocytopenia (HIT) undergoing cardiac surgery with cardiopulmonary bypass (CPB) . Since unfractionated heparin is contraindicated in HIT, bivalirudin has emerged as the main alternative, but high-quality data remain scarce. Methods: The review followed PRISMA 2020 guidelines and was prospectively registered in PROSPERO . Searches across PubMed, Embase, and Cochrane CENTRAL identified three cohort studies (170 patients) plus 16 case reports/series . Primary outcomes were major bleeding, thromboembolic events, and mortality ; secondary outcomes included transfusion needs, reoperation, circuit changes, and ICU/hospital stay. Results: Major bleeding: 10.6% pooled incidence (95% CI 6.4–16.9%). Thromboembolic events: 2.1% pooled incidence (95% CI 0.4–4.8%), with no CPB circuit thrombosis or oxygenator exchanges. Mortality: Early mortality ≤3%. Around 14% of patients required intraoperative dose adjustments , but ACT-guided protocols (480–520 s) ensured safe management. Case-based evidence confirmed feasibility in high-risk settings (pediatrics, reoperations, transplantation, renal impairment). Conclusions: Bivalirudin is a safe and effective alternative to heparin in HIT-positive patients requiring CPB, with low thrombotic risk and acceptable bleeding rates under strict ACT monitoring. Findings are consistent with international guidelines (ASH 2018, ACCP 2022) , though large randomized trials are still needed to refine dosing strategies and long-term outcomes