Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia

Fabes, Jez; Brunskill, Susan J; Curry, Nicola; Dorée, Carolyn; Stanworth, Simon

doi:10.1002/14651858.cd010649.pub2

Cited by 21 publications

(32 citation statements)

References 86 publications

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“…57 Randomized trials are increasingly informing optimal practice (eg, tranexamic acid, plasma), but the size and methodological quality of all the studies varies very considerably. 58 Exposure to extracorporeal circulation circuits and consequent blood-circuit surface interaction triggers a cascade of events that promote both bleeding and thrombosis. Platelet activation is a central event that contributes to both.…”

Section: Fviii-parg612mentioning

confidence: 99%

Illustrated State‐of‐the‐Art Capsules of the ISTH 2019 Congress in Melbourne, Australia

Ward

Andrews

2019

Research and Practice in Thrombosis and Haemostasis

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The 27th Congress of the International Society of Thrombosis and Haemostasis (ISTH) is an international conference held July 6‐10, 2019, in Melbourne, the capital of the state of Victoria, Australia. The ISTH congress has previously been held every other year, with the Scientific and Standardization Committee (SSC) meeting held annually, until 2019 when it became one combined annual meeting of the ISTH and SSC. The conference covers clinical and basic aspects of hemostasis and thrombosis, and this year includes 5 Plenary lectures and >50 State of Art (SOA) lectures, presented by internationally recognized speakers, as well as numerous oral session and poster presentations selected from submitted abstracts, including many early career and reach the world support recipients. This SOA review article in RPTH contains concise Illustrated Review Articles or ‘Capsules’ consisting of short text, three references and a figure, with topics including stroke, cancer‐associated thrombosis, hemophilia, coagulation, the interface between infection and inflammation, and in the experimental and discovery areas, megakaryocyte biology and platelet production, structure‐function of key receptors and coagulation factors, and emerging new roles for thrombotic/hemostatic factors. Together, these articles highlight novel findings which will advance knowledge and with the potential to change clinical practice and improve outcomes. It is hoped that conference attendees and followers will enjoy utilizing the images for ongoing education and during the conference for live tweeting during sessions, to assist in the broadcasting and promotion of the science to those unable to attend, or who have chosen to attend a concurrent session. Use #IllustratedReview and #ISTH2019 on social media.

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Section: Fviii-parg612mentioning

confidence: 99%

Illustrated State‐of‐the‐Art Capsules of the ISTH 2019 Congress in Melbourne, Australia

Ward

Andrews

2019

Research and Practice in Thrombosis and Haemostasis

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“…However, to date there have been no randomised controlled trials (RCT) that have compared the clinical efficacy and safety of PCC versus FFP in bleeding cardiac surgery patients who are not taking vitamin K antagonists (e.g., warfarin), and this was highlighted in a recent systematic review [4]. Several observational studies have demonstrated that PCC is safe in this setting and that its administration is associated with reduced blood transfusion requirements, albeit with no difference in other outcomes [5, 6].…”

Section: Introductionmentioning

confidence: 99%

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)

Green

Roberts

Field

et al. 2019

Trials

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Background: Fresh frozen plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during or immediately after cardiac surgery. In the United Kingdom prothrombin complex concentrate (PCC) is not licensed in this setting, although it is being used in Europe because it has a higher concentration of clotting factor levels, and it can be administered rapidly and in small volume, resulting in less volume overload during cardiac surgery. Methods: PROPHESY is a pragmatic, single-centre, open-label, randomised, controlled pilot trial that will assess whether it is feasible to perform a large trial in the future that will compare PCC versus FFP in patients who are bleeding (not on warfarin) and who require blood transfusion. Over a 15-month period, 50 patients will be randomised to PCC versus FFP if they develop active bleeding within 24 h of cardiac surgery and for whom the clinician has decided to administer FFP for treatment of bleeding. Standard laboratory and point-of-care assessments will be performed as per routine practice, and additional research blood samples will be taken at three time points to assess haemostasis. Subjects will be assessed daily up to hospital discharge or 30 days or death (whichever occurs first) and will be seen in follow-up for 90 days after surgery to assess for thromboembolic complications and hospital re-admission since discharge. Quality-of-life assessment will be performed pre-surgery and at 90 days post-surgery. We will also perform qualitative research with clinical experts and patients to explore the understanding of and experience with the interventions, as well as adherence to study procedures and protocol. Discussion: There have been no randomised controlled trials that have compared the safety and efficacy of FFP versus PCC in cardiac surgery patients who are bleeding. This pilot study will assess if individual components of a large trial are deliverable to assess the safety and efficacy of the two blood products in the future.

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“…However, to date there have been no randomized controlled trials (RCT) that have compared the clinical efficacy and safety of PCC versus FFP in bleeding cardiac surgery patients, who are not taking vitamin K antagonists (like warfarin), and this was highlighted in a recent systematic review [4].…”

Section: Introductionmentioning

confidence: 99%

A pragmatic pilot randomized phase II controlled trial of Prothrombin Complex Concentrates (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are Undergoing Heart Surgery (PROPHESY)

Green

Roberts

Cooper

et al. 2019

Preprint

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Background Fresh Frozen Plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during, or immediately after cardiac surgery. In the United Kingdom (UK) prothrombin complex concentrate (PCC) is not licensed in this setting although it is being used in Europe, because it has a higher concentration of clotting factor levels, and it can be administered rapidly and in small volume, resulting in less volume overload during cardiac surgery. Methods PROPHESY is a pragmatic single-centre, open-label, randomized, controlled pilot trial that will assess whether it is feasible to perform a large trial in the future that will compare PCC versus FFP in patients who are bleeding (not on warfarin) and who require blood transfusion. Over a 15-month period, 50 patients will be randomized to PCC versus FFP if they develop active bleeding within 24 hours of cardiac surgery, and for whom the clinician has decided to administer FFP for treatment of bleeding. Standard laboratory and Point-of-Care assessments will be performed as per routine practice, and additional research blood samples will be taken at three time-points to assess haemostasis. Subjects will be assessed daily up to hospital discharge or 30 days or death (whichever occurs first) and will be followed up for 90 days after surgery to assess for thromboembolic complications, and hospital re-admission since discharge. Quality of life assessment will be performed pre-surgery and at 90 days. We will also perform qualitative research with clinical experts and patients to explore the understanding and experience with the interventions, and adherence to study procedures and protocol. Discussion There have been no randomized control trials that have compared the safety and efficacy of FFP versus PCC in cardiac surgery in patients who are bleeding. This pilot study will assess if individual components of a large trial are deliverable to assess the safety and efficacy of the two blood products in the future.

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Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia

Abstract: Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia (Review)

Cited by 21 publications

References 86 publications

Illustrated State‐of‐the‐Art Capsules of the ISTH 2019 Congress in Melbourne, Australia

Illustrated State‐of‐the‐Art Capsules of the ISTH 2019 Congress in Melbourne, Australia

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)

A pragmatic pilot randomized phase II controlled trial of Prothrombin Complex Concentrates (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are Undergoing Heart Surgery (PROPHESY)

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