Assessment of effectiveness of major bleeding management: proposed definitions for effective hemostasis: communication from the SSC of the ISTH

Khorsand, Nakisa; Majeed, Ammar; Sarode, Ravindra; Beyer‐Westendorf, Jan; Schulman, Sam; Meijer, Karina

doi:10.1111/jth.13148

Cited by 82 publications

(69 citation statements)

References 32 publications

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“…Schulman et al () reported that PCC was effective in 65%, ineffective in 15% and produced a moderate response in the remainder. Their assessments of effectiveness were based on ISTH criteria (Khorsand et al , ). We observed a similar result in that PCC was effective in 77·6% of patients on warfarin, 75% on rivaroxaban and 72·5% of patients on apixaban, supporting the recommendation to use PCC for this indication (Makris et al , ), although there is no untreated group for comparison, so the true treatment effect is unknown.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

et al. 2018

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Summary This retrospective study investigated the efficacy and safety of prothrombin complex concentrates (PCCs) for management of major bleeding events (MBE) in 344 patients receiving the anticoagulants rivaroxaban, apixaban or warfarin during the period January 2016 to April 2018. Median (range) PCC dose was 2000 units (1000–4500). Intracranial haemorrhage (ICH) was the most common indication (137/344, 39·8%) for PCC use followed by gastrointestinal bleeding (93/344, 27%). ICH patients more frequently received rivaroxaban (62·5%) or apixaban (52·5%) compared to warfarin (34·5%), P = 0·002; and visceral bleeding patients received warfarin more frequently (24·2%) than rivaroxaban (5%) or apixaban (10%), P = 0·003. Median rivaroxaban and apixaban levels were 230 ng/ml (47–759) and 159 ng/ml (45–255). Median International Normalised Ratio pre‐ and post‐PCC in patients on warfarin were 3·4 (1·9–15·4) and 1·2 (1·0–1·9). Blood products use was the same between groups. Thirty‐day mortality and re‐bleeding rates in patients with ICH were 35% (P = 0·50) and 18% (P = 0·90) with no differences between the groups. Thrombosis occurred in 4·1% patients within 30 days with no difference between groups. Two of 91 (2·2%) patients with ICH only (both on warfarin) had ischaemic strokes within 30 days post‐PCC. In conclusion, there was no difference in the safety (thrombosis) or efficacy (30‐day mortality, re‐bleeding) in use of PCC for MBE in patients on warfarin, rivaroxaban or apixaban.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

et al. 2018

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“…In such situations, we relied on the other criteria in the ISTH document for the assessment of the effectiveness of PCCs. 20 Two independent investigators assessed the effectiveness of PCCs to add to the objectivity of the assessments. Second, we did not have a control group, managed conservatively by transfusion of blood products only, to be able to assess the additive effect of PCCs.…”

Section: Discussionmentioning

confidence: 99%

“…20 The criteria for the assessment of effectiveness of major bleeding management for 4 different bleeding types were presented: visible bleeding, nonvisible bleeding, musculoskeletal bleeding, and ICH. For non-ICH bleeding, data were collected on changes in the hemoglobin level, the need for transfusion of blood products, the need for intervention or surgery to stop the bleeding, and the administration of other hemostatic agents before or after PCCs.…”

Section: Assessment Of Outcomesmentioning

confidence: 99%

Management of rivaroxaban- or apixaban-associated major bleeding with prothrombin complex concentrates: a cohort study

Majeed¹,

Ågren

Holmström

et al. 2017

Blood

289

282

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“…Effectiveness, both in VKA reversal bleeding and bleeding coagulopathy, was established according to the definitions of the SSC/ISTH (Khorsand et al, ). In those with a bleeding coagulopathy, we considered the haemostasis restored if the patients reached the following points: (i) cessation of visible bleeding within 4 h of the end of PCC administration; (ii) no need for either further haemostatic agents or other blood products after 48 h; and (iii) blood loss during invasive interventions similar to that in a patient without coagulopathy.…”

Section: Methodsmentioning

confidence: 99%

Safety and effectiveness of a prothrombin complex concentrate in approved and off‐label indications

Marcos-Jubilar

García-Erce

Martínez‐Calle

et al. 2019

Transfusion Medicine

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Objective: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications.Background: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. Methods:This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. Results:A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of The administration of prothrombin complex concentrates is useful in approved and off-label indications for life-threatening bleeding and should be incorporated in massive bleeding protocols. other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%).Conclusion: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.

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Assessment of effectiveness of major bleeding management: proposed definitions for effective hemostasis: communication from the SSC of the ISTH

Cited by 82 publications

References 32 publications

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

Management of rivaroxaban- or apixaban-associated major bleeding with prothrombin complex concentrates: a cohort study

Safety and effectiveness of a prothrombin complex concentrate in approved and off‐label indications

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