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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
  1. 3F-PCC three-factor prothrombin complex concentrate, 4F-PCC four-factor prothrombin complex concentrate, aPCC activated prothrombin complex concentrate, aPTT activated partial thromboplastin time, ETP endogenous thrombin potential, INR international normalised ratio, PRBC packed red blood cells, PT prothrombin time, TGA thrombin generation assay, TEE thromboembolic event, TT thrombin time, VTE venous thromboembolism