Table 3 Case studies on the use of PCC for DOAC reversal, January 2013–February 2017
From: The impact of prothrombin complex concentrates when treating DOAC-associated bleeding: a review
Study citation | Study setting | Cases (N) | DOAC | PCC used | Outcomes following PCC administration |
|---|---|---|---|---|---|
Patients presenting with major bleeding | |||||
 Denetclaw et al. [96] | Gluteal arterial extravasation | 1 | Apixaban | 3F-PCC (Profilnine®) | • Clinical examination suggested the haematoma had not expanded since PCC administration • The patient was discharged in a stable condition on Day 7 • No TEEs or VTEs reported |
 Diaz et al. [97] | GI bleeding | 5 | Dabigatran | 4F-PCC (Octaplex®) | • Cessation of bleeding in 4/5 patients • No TEEs or VTEs reported during 6 months of follow-up |
 Dibu et al. [86] | ICH | 5 | Rivaroxaban, apixaban, dabigatran | aPCC (FEIBA®) | • None of the patients had ICH expansion • No TEEs, VTEs or haemorrhagic complications reported |
 Durie et al. [101] | Life-threatening bleed due to trauma | 1 | Apixaban | 4F-PCC (Kcentra®/Beriplex®) | • Despite aggressive treatment, and PCC administered at the maximum dose, haemostasis was not achieved and the patient died |
 Faust et al. [102] | Subdural haematoma | 3 | Rivaroxaban | 3F-PCC (Profilnine®) | • Haematoma volume remained stable in all patients • No TEEs or VTEs reported |
 Faust et al. [107] | Subdural haematoma | 2 | Apixaban | 3F-PCC (Profilnine®) | • Minimal or no progression in haematoma volume • No TEEs or VTEs reported |
 Faust and Peterson [87] | Intracerebral haemorrhage | 1 | Dabigatran | aPCC (FEIBA®) | • Coagulation parameters were not normalised • Despite initial increase in haematoma, the patient avoided surgical intervention and remained stable • After approximately 2 weeks, the patient developed a new ischemic stroke and was discharged to a hospice |
 Jones et al. [104] | GI bleeding and haemorrhagic shock | 1 | Dabigatran | 4F-PCC (Kcentra®/Beriplex®) | • Rapid correction of coagulation parameters and achievement of haemostasis • No TEEs or VTEs reported |
 Kauffmann et al. [98] | Subdural haematoma | 1 | Rivaroxaban | 4F-PCC (Kanokad®) | • Improvement in TGA parameters lasting at least 18 h (normalisation of lag time, elevated peak height and ETP) • Favourable clinical outcome • No TEEs or VTEs reported |
 Masotti et al. [27] | GI bleeding | 8 | Dabigatran | 4F-PCC (Confidex®/Beriplex®) | • Cessation of bleeding, despite uncorrected coagulation parameters (aPTT, PT/INR) • No TEEs or VTEs reported |
 McGovern et al. [99] | GI bleeding | 1 | Dabigatran | 4F-PCC (unspecified) | • Normalisation of coagulation profile (PT, INR, aPTT) • No active sites of bleeding identified, and no further blood transfusions required • Patient discharged 4 days later, without experiencing any further morbidity related to his condition • No TEEs or VTEs reported |
 Means et al. [103] | Rectal bleeding | 1 | Rivaroxaban | 3F-PCC (Profilnine®) | • PCC administration helped control bleeding • No TEEs or VTEs reported |
 Rinehart et al. [88] | Subdural haematoma | 1 | Apixaban | aPCC (FEIBA®) | • PT and INR normalised within 24 h • Slight improvement in subdural haematoma on Day 2 • Patient remained stable, with further improvement in the subdural haematoma before discharge on Day 7 • No TEEs or VTEs reported |
 Schulman et al. [100] | Subdural haematoma | 1 | Dabigatran | aPCC (FEIBA®) | • Normalisation of thrombin time at Day 3 • Patient underwent an uneventful haematoma drainage procedure and was discharged a day later • No TEEs or VTEs reported |
Intra-axial haemorrhage | 1 | • Mild increase in haematoma size after 3 days; no further progression of symptoms • No TEEs or VTEs reported | |||
Pericardial bleeding | 1 | • Cessation of bleeding • No TEEs or VTEs reported | |||
Upper GI bleeding | 1 | • Stabilisation of clinical condition • No TEEs or VTEs reported | |||
 Smith et al. [106] | Left frontal lobe parenchymal haemorrhage | 1 | Rivaroxaban | aPCC (FEIBA®) | • After aPCC administration, the patient was admitted to the trauma in-patient unit; neurological exam remained normal for 24 h and the patient was discharged • No TEEs or VTEs reported |
Patients requiring urgent/emergent surgery | |||||
 Beynon et al. [89] | Emergency neurosurgery | 2 | Apixaban | 4F-PCC (Beriplex®) | • No bleeding complications occurred during surgery • No symptoms suggestive of thromboembolic events |
 Chic Acevedo et al. [90] | Urgent surgery due to an abdominal haematoma | 1 | Rivaroxaban | 4F-PCC (Octaplex®) | • PT normalisation • No complications reported during or after surgery |
 Dager et al. [95] | Ablation procedure | 1 | Dabigatran | aPCC (FEIBA®) | • Normalisation of INR and aPTT, but not thrombin time • Bleeding slowed 5 min into the infusion and had stopped by the end of the 15-min infusion • No evidence of thrombosis observed |
 Liu et al. [105] | Coronary artery bypass graft | 1 | Rivaroxaban | 4F-PCC (Kcentra®/Beriplex®) | • Patient lost 650 mL blood during the procedure, necessitating the transfusion of 2 units each of PRBCs and platelets • Patient was discharged with no sequalae on postoperative day 9 • Follow-up visit at 1 month did not reveal any new significant events • No TEEs or VTEs reported |
 Maurice-Szamburski et al. [91] | Subdural haematoma requiring neurosurgical intervention | 1 | Rivaroxaban | aPCC (FEIBA®) | • No abnormal bleeding during surgery • Good surgical result with no rebleeding • No TEEs or VTEs reported |
 Neyens et al. [92] | Subdural haematoma requiring neurosurgical intervention | 1 | Dabigatran | aPCC (FEIBA®) | • Therapeutic impact uncertain • Coagulation parameters (aPTT and TT) remained prolonged, delaying surgical intervention; thromboelastography may be more appropriate for monitoring dabigatran anticoagulation • No TEEs or VTEs reported |
 Puttick et al. [93] | Emergency surgery for an incarcerated femoral hernia | 1 | Dabigatran | aPCC (FEIBA®) | • Surgery was successful, with no complications • The patient made an uneventful recovery and was discharged the next day • No TEEs or VTEs reported |
 Wong and Keeling [94] | Urgent percutaneous transhepatic drainage of a gall bladder empyema | 1 | Dabigatran | aPCC (FEIBA®) | • No bleeding complications occurred during surgery and the clinical state of the patient improved • No TEEs or VTEs reported |