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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All patients received an old PCC that was withdrawn in 1994; all patients had underlying diseases predisposing them to thrombosis or DIC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.