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Table 1 Description of the type of studies, number of patients included and patient group, dose of PCC, target INR, outcome 1 and 2, transfusions and thromboembolic events

From: A review of the clinical utility of INR to monitor and guide administration of prothrombin complex concentrate to orally anticoagulated patients

Author Study No. Area Intervention
dose PCC/kg
Target INR Outcome 1 Outcome 2 Transfusion + Vit. K Thromboembolic events
8) Demeyere et al. 2010 Randomised clinical trial 40 (20 pt. treated with PCC, 20 with FFP). 9 patients reached target INR spontaneously which leaves 16 pt. in PCC group Cardiopulmonary PCC (PPSB-SD Cofact, SANQUIN, CAF-DCF, Belgium, factor 4, inactive dosage based on pt weight, initial and target INR <1.5 No. of patients reaching and time to target INR.
6/15 reached target INR after 60 min. (Data for one was missing and 4 had spontaneous normalization of their INR)
6/20 in PCC group needed additional PCC
Amount and no. of postoperative bleedings.
None in PCC group suffered from post-op bleeding
33 U of red blood cells for 16 pt. in PCC group. No mention of vitamin K None
12) Van Aart et al. 2005 Open, prospective, randomized controlled trial w. two arms 93 Invasive procedures or active bleeding PCC (Cofact, Sanquin, Amsterdam, the Netherlands, factor 4). Treatment for group A: single dose of 20 ml PCC corresponding with 500 IU/ 7IU/kg. Group B: individualized dose based on pt weight, initial and target INR Target INR for small intervention or minor bleeding: 2.1, 1.5 for major bleeding After 15 min. 43% had reached target INR in group A respectively 89 % in group B In group A three pt. continued to bleed and was given a 2nd dose PCC. In group B one pt. continued to bleed and was given a 2nd dose PCC. They had reached their target INR. All interventions were performed without bleeding complications and all existing bleeding stopped No FFP or platelet concentrates were administered. No information on packed red blood cells. All pt received vitamin K Two non-fatal non-bleeding cerebrovascular events occurred, one in each group
13) Pabinger et al.
Prospective multinational clinical trial 43 Intervention (26) or acute bleeding (17) PCC (Beriplex P/N, CSL Behring GmbH, Marburg, Germany, factor 4) 25-35-50 IU/kg depending on initial INR 2-3.9, 4-6 or >6 <1.3 - 1.3 93% INR normalization to < 1.3 30 minutes after PCC. In the remaining three pt. INR was 1.4 Clinical haemostatic efficacy: 98% judged ”very good” or ”satisfactory” Nothing on transfusions reported. 88% received vitamin K One fatal pulmonary embolism
14) Lorenz et al. 2007 Prospective cohort study 8 Invasive procedures or active bleeding Mean PCC (Beriplex P/N, CSL Behring GmbH, Marburg, Germany, factor 4) doses 57IU/kg in first round. 2 pt. received a second dose of 1500IU and 3500IU respectively No target INR listed Changes from baseline INR at 10, 30 and 60 min after PCC. Mean baseline INR 3.4 >10 min 7/8 INR <1.3, 1/8 INR:1.4 Clinical effectiveness rated by cessation of existing bleeding: 7/8 rated very good, 1/8 satisfactory No transfusions reported. One pt received vitamin K None
15) Riess et al. 2006 Open-labelled prospective clinical study 60 Major and minor surgery PCC(Octaplex, Octapharma, Vienne, Austria, factor 4) 41.4 IU/kg PT% endpoint-PT% BL*kg = IU Major surgery 1.3-1.1, Minor surgery 2.1-1.5 Target INR after PCC at 10, 30 and 60 min. 88%/91% respectively met criteria Clinical efficacy, 3 point verbal scale (none, moderate, excellent) 56/56 was rated ”excellent” even though 5 did not respond in regard to INR No transfusions reported. 24 pt received vitamin K None
16) Yasaka et al. 2004-05 Prospective study 42 27 cerebral haemorrhage, 15 with major nonneurological haemorrhage or invasive procedures PCC (PPSB-HT Nichiyaku, Nihon Pharmaceutical, Toyko, Japan, factor 4) 200-1500IU. INR after 10 and 60 min. No target INR listed 30 pt. received median 8.8IU/kg, values decreased from median 2.49 to 1.19. 18.4IU/kg and 26.0IU/kg INR values decreased from median 2.33 to 0.96 Clinical evaluation: enlargement of haematoma in two pt. the one re-increased in INR from 1.48 to 2.72 half a day after INR reversal by 1000IU PCC, the other had syst. BP >200mm hg and low INR. 6 pt were evacuated with easy haemostasis during operation No transfusions reported. 31/42 pt received vitamin K None
17) Lavenne-Pardonge et al. 2006 Prospective study 14 Mixed group in immediate need of reversal PPSB-Solvent Detergent by C.A.F.-D.C.F., factor 4) PCC dosed after weight. All pt. received only one dose INR <2 for moderate bleeding, <1.5 for severe bleeding and cardiovascular procedure 11/12 reached target after 15 min and 13/14 after 60 min. (1/14 had an INR of 1.56) Bleeding stopped in the 6 pt. treated for this/ no bleeding complications occurred during surgery for pt. treated prior to an operation No transfusion reported. 80% received vitamin K None
9) Lubetsky et al. 2004 Prospective non-randomized, non-controlled, open-labelled, multicenter phase II study 20 Bleeding (10) Surgery (10) Octaplex (Octapharma, Vienna, Austria, factor 4): Bleeding group: 23.6IU/kg +/-7.0, surgery group: 31.2IU/kg +/-7.6 No target INR listed Baseline INR in bleeding group: 7.1+/-2.5, surgery group; 5.0+/-2.8. Mean INR values declined 6.1+/-2.8 to 1.5+/-0.3 within 10 minutes. Three point scale, good, moderate or none 1h post-infusion.Bleeding group 9/10 was rated good, 1/10 moderate. Surgery group: 8/10 good, 2/10 moderate. No information on the INR of these three pt. All three were transfused with 2-7 units of packed cells. 7/20 vitamin K, median dose 2.3 mg None
18) Schick et al. 2009 Retrospective study of case notes 50 (12 pt treated w. anticoagulant in need of reversal) Intervention (Beriplex P/N. CSL Behring, Marburg, Germany, factor 4) Median dose 1500 IU, 22IU/kg <1.7 Change in baseline INR after PCC. Mean INR decreased significantly from baseline 2.8 to 1.5 at 180+/-31 min. Bleeding: No major per operative bleeding was reported One pt. was in need of blood component replacement therapy with FFP, platelets and red blood cells, after PCC administration7/12 received vitamin K None
19) Chong et al. 2009 Observational study 7 Neurological 4 with subdural hematoma,3 had intracerebrale hematomas PCC (Profilenine SD, Grisols Biologicale Inc, Los Angeles, CA, USA, factor 3), Median dose 28.5IU/kg Normalization of INR defined as <1.5 Median time to INR normalization 420 min Three died. Two had hematoma growth, one cause of dead not listed 6/7 pt received vitamin K 1 pulmonary embolism (in a pt. who had received a relatively lower dose)