Dabigatran-induced Gastrointestinal Bleed Treated by 4-factor Prothrombin Complex Concentrate in a Tertiary Care Hospital in Sikkim
Case report published in The Journal of the Association of Physicians of India (2026)
Abstract
An immediate need exists for a safe, quick, and effective reversal agent in patients who present with anticoagulant-induced major bleed. Dabigatran, a newer oral anticoagulant and a direct thrombin inhibitor (DTI), can also induce bleeding risk. Idarucizumab is a specific dabigatran reversal drug that the United States Food and Drug Administration (US FDA) has approved in the event of a significant bleeding caused by this drug. In this particular drug-related bleeding, it can be challenging to precisely dose alternative reversal agents like prothrombin complex concentrates (PCCs) and activated PCCs (aPCCs) depending on coagulation characteristics. Additionally, they may result in thromboembolic problems. Despite these drawbacks, the inability to get idarucizumab may necessitate the use of these medications in cases of life-threatening bleeding. We describe the case of a 65-year-old male who reported to the hospital with coagulopathy, anemia, and fresh bleeding per rectum (Hb: 5.8 gm/dL, PT 20.02 seconds, INR: 1.55). He was on dabigatran for the past 1 month. Even after stopping dabigatran, injection of vitamin K, 4 units of blood transfusion, and 8 units of fresh frozen plasma (FFP), he was still bleeding, with fall in hemoglobin level. Following the administration of PCC, he significantly improved, and no additional transfusion products were needed. He could be sent home after 4 days. After 1 month, he returned for follow-up with no further complications.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
An immediate need exists for a safe, quick, and effective reversal agent in patients who present with anticoagulant-induced major bleed.
Why This Matters for Hirudotherapy
This case report describes a 65-year-old man on dabigatran for one month who presented with lower GI bleeding, anemia, and coagulopathy (Hb 5.8 g/dL, INR 1.55) and continued bleeding despite dabigatran withdrawal, vitamin K, four units of blood, and eight units of fresh frozen plasma, then improved markedly after prothrombin complex concentrate (PCC) and was discharged after four days with no complications at one-month follow-up; the authors note PCC/aPCC as alternatives when the FDA-approved specific reversal agent idarucizumab is unavailable. For ASH it adds to the reversal/safety literature surrounding dabigatran, an oral direct thrombin inhibitor in the conceptual lineage of hirudin from medicinal-leech research. Caveat: this is a single uncontrolled case report, the lowest tier of clinical evidence, so the favorable PCC response cannot be generalized; note also that the abstract states FDA approval only for idarucizumab, not for PCC in this indication, and dabigatran itself is synthetic rather than leech-derived.
Citation
Dabigatran-induced Gastrointestinal Bleed Treated by 4-factor Prothrombin Complex Concentrate in a Tertiary Care Hospital in Sikkim
Dhakal M et al. · The Journal of the Association of Physicians of India, 2026
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