Nazish K Hashmi1, Kamrouz Ghadimi1, Amudan J Srinivasan2, Yi-Ju Li3, Robert D Raiff4, Jeffrey G Gaca5, Adam G Root4, Yaron D Barac5, Thomas L Ortel6, Jerrold H Levy1,5, Ian J Welsby1. 1. Department of Anesthesiology & Critical Care, Divisions of Cardiothoracic Anaesthesia & Critical Care Medicine, Duke University School of Medicine, Durham, NC, USA. 2. Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 3. Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA. 4. Center for Medication Policy, Department of Pharmacy, Duke University Hospital Durham, NC, USA. 5. Department of Surgery, Division of Cardiothoracic Surgery, Duke University School of Medicine, Durham, NC, USA. 6. Departments of Pathology, Hematology, and Medicine, Duke University School of Medicine, Durham, NC, USA.
Abstract
BACKGROUND/ OBJECTIVES: Prothrombin complex concentrates (PCC) are increasingly administered off-label in the United States to treat bleeding in cardiovascular surgical patients and carry the potential risk for acquired thromboembolic side-effects after surgery. Therefore, we hypothesized that the use of low-dose 3-factor (3F) PCC (20-30 IU/kg), as part of a transfusion algorithm, reduces bleeding without increasing postoperative thrombotic/thromboembolic complications. MATERIALS/ METHODS: After IRB approval, we retrospectively analysed 114 consecutive, complex cardiovascular surgical patients (age > 18 years), between February 2014 and June 2015, that received low-dose 3F-PCC (Profilnine® ), of which seven patients met established exclusion criteria. PCC was dosed according to an institutional perioperative algorithm. Allogeneic transfusions were recorded before and after PCC administration (n = 107). The incidence of postoperative thromboembolic events was determined within 30 days of surgery, and Factor II levels were measured in a subset of patients (n = 20) as a quality control measure to avoid excessive PCC dosing. RESULTS: Total allogeneic blood product transfusion reached a mean of 12·4 ± 9·9 units before PCC and 5·0 ± 6·3 units after PCC administration (P < 0·001). The mean PCC dose was 15·8 ± 7·1 IU/kg. Four patients (3·8%) each experienced an ischaemic stroke on postoperative day 1, 2, 4 and 27. Seven patients (6·5%) had acquired venous thromboembolic disease within 10 days of surgery. Median factor II level after transfusion algorithm adherence and PCC administration was 87%. CONCLUSIONS: 3F-PCC use for refractory bleeding after cardiovascular surgery resulted in reduced transfusion of allogeneic blood and blood products. Adherence to this algorithmic approach was associated with an acceptable incidence of postoperative thrombotic/thromboembolic complications.
BACKGROUND/ OBJECTIVES:Prothrombincomplex concentrates (PCC) are increasingly administered off-label in the United States to treat bleeding in cardiovascular surgical patients and carry the potential risk for acquired thromboembolic side-effects after surgery. Therefore, we hypothesized that the use of low-dose 3-factor (3F) PCC (20-30 IU/kg), as part of a transfusion algorithm, reduces bleeding without increasing postoperative thrombotic/thromboembolic complications. MATERIALS/ METHODS: After IRB approval, we retrospectively analysed 114 consecutive, complex cardiovascular surgical patients (age > 18 years), between February 2014 and June 2015, that received low-dose 3F-PCC (Profilnine® ), of which seven patients met established exclusion criteria. PCC was dosed according to an institutional perioperative algorithm. Allogeneic transfusions were recorded before and after PCC administration (n = 107). The incidence of postoperative thromboembolic events was determined within 30 days of surgery, and Factor II levels were measured in a subset of patients (n = 20) as a quality control measure to avoid excessive PCC dosing. RESULTS: Total allogeneic blood product transfusion reached a mean of 12·4 ± 9·9 units before PCC and 5·0 ± 6·3 units after PCC administration (P < 0·001). The mean PCC dose was 15·8 ± 7·1 IU/kg. Four patients (3·8%) each experienced an ischaemic stroke on postoperative day 1, 2, 4 and 27. Seven patients (6·5%) had acquired venous thromboembolic disease within 10 days of surgery. Median factor II level after transfusion algorithm adherence and PCC administration was 87%. CONCLUSIONS:3F-PCC use for refractory bleeding after cardiovascular surgery resulted in reduced transfusion of allogeneic blood and blood products. Adherence to this algorithmic approach was associated with an acceptable incidence of postoperative thrombotic/thromboembolic complications.
Authors: Philip E Greilich; Chad F Brouse; Joseph Beckham; Michael E Jessen; Erika J Martin; Marcus E Carr Journal: Thromb Res Date: 2002-03-15 Impact factor: 3.944
Authors: Keyvan Karkouti; W Scott Beattie; Ramiro Arellano; Tim Aye; Jean S Bussieres; Jeannie L Callum; Davy Cheng; Lee Heinrich; Blaine Kent; Trevor W R Lee; Charles MacAdams; C David Mazer; Brian Muirhead; Antoine G Rochon; Fraser D Rubens; Corey Sawchuk; Shaohua Wang; Terrence Waters; Bill I Wong; Terrence M Yau Journal: Circulation Date: 2008-07-07 Impact factor: 29.690
Authors: Prajeeda M Nair; Matthew J Rendo; Kristin M Reddoch-Cardenas; Jason K Burris; Michael A Meledeo; Andrew P Cap Journal: Semin Hematol Date: 2020-07-27 Impact factor: 3.851