Clinical trial NCT04244981 - References

Cardiac Surgical Procedures — Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery

Citation(s)

•   Alfirevic A, Xu M, Johnston D, Figueroa P, Koch CG
  Transfusion increases the risk for vasoplegia after cardiac operations. Ann Thorac Surg. 2011 Sep;92(3):812-9. doi: 10.1016/j.athoracsur.2011.04.020. Epub 2011 Jul 23.
•   Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G
  Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):160S-198S. doi: 10.1378/chest.08-0670.
•   Bux J
  Transfusion-related acute lung injury (TRALI): a serious adverse event of blood transfusion. Vox Sang. 2005 Jul;89(1):1-10. doi: 10.1111/j.1423-0410.2005.00648.x.
•   Cappabianca G, Mariscalco G, Biancari F, Maselli D, Papesso F, Cottini M, Crosta S, Banescu S, Ahmed AB, Beghi C
  Safety and efficacy of prothrombin complex concentrate as first-line treatment in bleeding after cardiac surgery. Crit Care. 2016 Jan 6;20:5. doi: 10.1186/s13054-015-1172-6.
•   Cromwell C, Aledort LM
  FEIBA: a prohemostatic agent. Semin Thromb Hemost. 2012 Apr;38(3):265-7. doi: 10.1055/s-0032-1309286. Epub 2012 Mar 29.
•   Dacey LJ, Munoz JJ, Baribeau YR, Johnson ER, Lahey SJ, Leavitt BJ, Quinn RD, Nugent WC, Birkmeyer JD, O'Connor GT
  Reexploration for hemorrhage following coronary artery bypass grafting: incidence and risk factors. Northern New England Cardiovascular Disease Study Group. Arch Surg. 1998 Apr;133(4):442-7. doi: 10.1001/archsurg.133.4.442.
•   Despotis G, Eby C, Lublin DM
  A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion. 2008 Mar;48(1 Suppl):2S-30S. doi: 10.1111/j.1537-2995.2007.01573.x. No abstract available.
•   Eitz T, Schenk S, Fritzsche D, Bairaktaris A, Wagner O, Koertke H, Koerfer R
  International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement. Ann Thorac Surg. 2008 Mar;85(3):949-54; discussion 955. doi: 10.1016/j.athoracsur.2007.08.071.
•   Erber WN, Perry DJ
  Plasma and plasma products in the treatment of massive haemorrhage. Best Pract Res Clin Haematol. 2006;19(1):97-112. doi: 10.1016/j.beha.2005.01.026.
•   Fariborz Farsad B, Golpira R, Najafi H, Totonchi Z, Salajegheh S, Bakhshandeh H, Hashemian F
  Comparison between Prothrombin Complex Concentrate (PCC) and Fresh Frozen Plasma (FFP) for the Urgent Reversal of Warfarin in Patients with Mechanical Heart Valves in a Tertiary Care Cardiac Center. Iran J Pharm Res. 2015 Summer;14(3):877-85.
•   Franchini M, Lippi G
  Prothrombin complex concentrates: an update. Blood Transfus. 2010 Jul;8(3):149-54. doi: 10.2450/2010.0149-09. No abstract available.
•   Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R
  Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. doi: 10.1016/S0140-6736(14)61685-8. Epub 2015 Feb 27.
•   Green L, Roberts N, Cooper J, Field J, Gill R, Klein A, Agarwal S, Stanworth S, Johnston A, Monk V, O'Brien B
  A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY). Trials. 2019 Dec 9;20(1):684. doi: 10.1186/s13063-019-3759-8.
•   Hellstern P, Halbmayer WM, Kohler M, Seitz R, Muller-Berghaus G
  Prothrombin complex concentrates: indications, contraindications, and risks: a task force summary. Thromb Res. 1999 Aug 15;95(4 Suppl 1):S3-6. doi: 10.1016/s0049-3848(99)00077-8. No abstract available.
•   Hellstern P
  Production and composition of prothrombin complex concentrates: correlation between composition and therapeutic efficiency. Thromb Res. 1999 Aug 15;95(4 Suppl 1):S7-12. doi: 10.1016/s0049-3848(99)00078-x.
•   Huttner HB, Schellinger PD, Hartmann M, Kohrmann M, Juettler E, Wikner J, Mueller S, Meyding-Lamade U, Strobl R, Mansmann U, Schwab S, Steiner T
  Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke. 2006 Jun;37(6):1465-70. doi: 10.1161/01.STR.0000221786.81354.d6. Epub 2006 May 4.
•   Karkouti K, Callum J, Crowther MA, McCluskey SA, Pendergrast J, Tait G, Yau TM, Beattie WS
  The relationship between fibrinogen levels after cardiopulmonary bypass and large volume red cell transfusion in cardiac surgery: an observational study. Anesth Analg. 2013 Jul;117(1):14-22. doi: 10.1213/ANE.0b013e318292efa4. Epub 2013 May 17.
•   Kaspereit F, Hoffmann S, Pragst I, Dickneite G
  Prothrombin complex concentrate mitigates diffuse bleeding after cardiopulmonary bypass in a porcine model. Br J Anaesth. 2010 Nov;105(5):576-82. doi: 10.1093/bja/aeq216. Epub 2010 Aug 17.
•   Khuri SF MA, Valeri CR
  The effects of cardiopulmonary bypass on hemostasis. Loscabo J, Schafer AI, eds. Thrombosis & Hemorrhage. Cambridge: Blackwell Science. 1993;1993:1051-1073.
•   Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, Filipescu DC, Fries D, Gorlinger K, Haas T, Imberger G, Jacob M, Lance M, Llau J, Mallett S, Meier J, Rahe-Meyer N, Samama CM, Smith A, Solomon C, Van der Linden P, Wikkelso AJ, Wouters P, Wyffels P
  Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2013 Jun;30(6):270-382. doi: 10.1097/EJA.0b013e32835f4d5b. Erratum In: Eur J Anaesthesiol. 2014 Apr;31(4):247.
•   Leissinger CA, Blatt PM, Hoots WK, Ewenstein B
  Role of prothrombin complex concentrates in reversing warfarin anticoagulation: a review of the literature. Am J Hematol. 2008 Feb;83(2):137-43. doi: 10.1002/ajh.21046.
•   Levy JH, Tanaka KA, Dietrich W
  Perioperative hemostatic management of patients treated with vitamin K antagonists. Anesthesiology. 2008 Nov;109(5):918-26. doi: 10.1097/ALN.0b013e3181895bd8.
•   Linden MD
  The hemostatic defect of cardiopulmonary bypass. J Thromb Thrombolysis. 2003 Dec;16(3):129-47. doi: 10.1023/B:THRO.0000024051.12177.e9.
•   Mariscalco G, Biancari F, Juvonen T, Zanobini M, Cottini M, Banach M, Murphy GJ, Beghi C, Angelini GD
  Red blood cell transfusion is a determinant of neurological complications after cardiac surgery. Interact Cardiovasc Thorac Surg. 2015 Feb;20(2):166-71. doi: 10.1093/icvts/ivu360. Epub 2014 Nov 2.
•   Moulton MJ, Creswell LL, Mackey ME, Cox JL, Rosenbloom M
  Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg. 1996 May;111(5):1037-46. doi: 10.1016/s0022-5223(96)70380-x.
•   Nienaber U, Innerhofer P, Westermann I, Schochl H, Attal R, Breitkopf R, Maegele M
  The impact of fresh frozen plasma vs coagulation factor concentrates on morbidity and mortality in trauma-associated haemorrhage and massive transfusion. Injury. 2011 Jul;42(7):697-701. doi: 10.1016/j.injury.2010.12.015. Epub 2011 Mar 9.
•   Ortmann E, Besser MW, Sharples LD, Gerrard C, Berman M, Jenkins DP, Klein AA
  An exploratory cohort study comparing prothrombin complex concentrate and fresh frozen plasma for the treatment of coagulopathy after complex cardiac surgery. Anesth Analg. 2015 Jul;121(1):26-33. doi: 10.1213/ANE.0000000000000689.
•   Ottino G, De Paulis R, Pansini S, Rocca G, Tallone MV, Comoglio C, Costa P, Orzan F, Morea M
  Major sternal wound infection after open-heart surgery: a multivariate analysis of risk factors in 2,579 consecutive operative procedures. Ann Thorac Surg. 1987 Aug;44(2):173-9. doi: 10.1016/s0003-4975(10)62035-8.
•   Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group
  Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.
•   Pabinger-Fasching I
  Warfarin-reversal: results of a phase III study with pasteurised, nanofiltrated prothrombin complex concentrate. Thromb Res. 2008;122 Suppl 2:S19-22. doi: 10.1016/S0049-3848(08)70005-7.
•   Parr KG, Patel MA, Dekker R, Levin R, Glynn R, Avorn J, Morse DS
  Multivariate predictors of blood product use in cardiac surgery. J Cardiothorac Vasc Anesth. 2003 Apr;17(2):176-81. doi: 10.1053/jcan.2003.44.
•   Patanwala AE, Acquisto NM, Erstad BL
  Prothrombin complex concentrate for critical bleeding. Ann Pharmacother. 2011 Jul;45(7-8):990-9. doi: 10.1345/aph.1Q096. Epub 2011 Jul 5.
•   Safaoui MN, Aazami R, Hotz H, Wilson MT, Margulies DR
  A promising new alternative for the rapid reversal of warfarin coagulopathy in traumatic intracranial hemorrhage. Am J Surg. 2009 Jun;197(6):785-90. doi: 10.1016/j.amjsurg.2008.04.003. Epub 2008 Aug 22.
•   Sellman M, Intonti MA, Ivert T
  Reoperations for bleeding after coronary artery bypass procedures during 25 years. Eur J Cardiothorac Surg. 1997 Mar;11(3):521-7. doi: 10.1016/s1010-7940(96)01111-6.
•   Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S
  Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. doi: 10.1016/j.athoracsur.2007.02.099.
•   Song HK, Tibayan FA, Kahl EA, Sera VA, Slater MS, Deloughery TG, Scanlan MM
  Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery. J Thorac Cardiovasc Surg. 2014 Mar;147(3):1036-40. doi: 10.1016/j.jtcvs.2013.11.020. Epub 2013 Dec 22.
•   Stanworth SJ, Brunskill SJ, Hyde CJ, McClelland DB, Murphy MF
  Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials. Br J Haematol. 2004 Jul;126(1):139-52. doi: 10.1111/j.1365-2141.2004.04973.x.
•   Sun JC, Davidson MJ, Lamy A, Eikelboom JW
  Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.
•   Vigue B, Ract C, Tremey B, Engrand N, Leblanc PE, Decaux A, Martin L, Benhamou D
  Ultra-rapid management of oral anticoagulant therapy-related surgical intracranial hemorrhage. Intensive Care Med. 2007 Apr;33(4):721-5. doi: 10.1007/s00134-007-0528-z. Epub 2007 Jan 27.
•   Weber CF, Klages M, Zacharowski K
  Perioperative coagulation management during cardiac surgery. Curr Opin Anaesthesiol. 2013 Feb;26(1):60-4. doi: 10.1097/ACO.0b013e32835afd28.
•   Weinberger J, Cipolle M
  Optimal Reversal of Novel Anticoagulants in Trauma. Crit Care Clin. 2017 Jan;33(1):135-152. doi: 10.1016/j.ccc.2016.08.005.
•   Zacharias A, Habib RH
  Factors predisposing to median sternotomy complications. Deep vs superficial infection. Chest. 1996 Nov;110(5):1173-8. doi: 10.1378/chest.110.5.1173.

Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial

Details for clinical trial NCT04244981