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
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. 2007 | 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) |