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 |
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deficiencies of coagulation factors | 5 | 5 | Thrombotic events (fatal) | All patients received an old PCC that was withdrawn in 1994; all patients had underlying diseases predisposing them to thrombosis or DIC |