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Table 2 Studies reporting thrombogenic complications associated with the use of PCCs

From: Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

Publication Study type PCC indication Number of patients Number of thrombotic complications Nature of complications Notes
Lusher [11] Physician survey and registry Haemophilia Not available (150 physicians surveyed) 72 (reported over a 4-year period) Various (for example, deep venous thrombosis of the leg, pulmonary embolus, DIC) Increased risk among patients receiving large, repeated doses of PCC
Lankiewicz and colleagues [15] Retrospective review Warfarin reversal 58 4 Deep vein thrombosis (n = 2), non-ST elevation myocardial infarction (n = 2) Thrombotic complications were not attributable to PCC therapy
van Aart and colleagues [16] Prospective, randomised controlled trial Oral anticoagulation reversal (acenocoumarol or phenprocoumon) 93 2 Thrombotic stroke (n = 2) Both patients were elderly and had atrial fibrillation; one had vascular disease and the other had a large haematoma
Preston and colleagues [17] Prospective, uncontrolled trial Warfarin reversal 42 1 Thrombotic stroke Stroke occurred following leg amputation, 48 hours after PCC treatment. Patient had peripheral vascular disease
Pabinger- Fasching and colleagues [18, 55] Prospective, uncontrolled trial Oral anticoagulation reversal (vitamin K antagonists) 43 1 Suspected pulmonary embolism (fatal) Patient had risk of thrombosis due to metastatic gastrointestinal cancer and atrial fibrillation
Bagot and colleagues [19] Case report Warfarin reversal 1 1 Myocardial infarction (fatal) No definite causal link with PCC administration; patient may have had DIC related to abdominal sepsis
Warren and Simon [20] Case report Warfarin reversal 1 1 Intracardial thrombosis (fatal) Patient had a history of ischaemic stroke and deep venous thrombosis; general disturbance of coagulation
Kohler and colleagues [22] Case reports (n = 5) Perioperative setting, acquired deficiencies of coagulation factors 5 5 Thrombotic events (fatal) All patients received an old PCC that was withdrawn in 1994; all patients had underlying diseases predisposing them to thrombosis or DIC
  1. DIC, disseminated intravascular coagulation; PCC, prothrombin complex concentrate.