| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| pulmonary embolism | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ACTSG (Hull) sub-group, 1992 | vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.00 [0.00; NaN] | | THESEE, 1997 | vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 1.53 [0.26; 9.09] | | Campbell, 1998 | vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| ACTSG (Hull) sub-group, 1992 | Tinzaparin, 175 IU/kg once daily, 6 days (n=97) vs. Unfractioned heparin: bolus 5000 IU, infusion 29 760–40 320 IU/d (n=103) | patients with objectively documented PE and underlying proximal deep vein thrombosi sub group of patients with objectively documented PE in a trial enrolling patients with proximal-vein thrombosis | double blind Parallel groups Sample size: 97/103 Primary endpoint: none defined FU duration: 3mo | | THESEE, 1997 | Tinzaparin, 175 IU/kg once daily, 5 days (n=301) vs. Unfractioned heparin: bolus 50 IU/kg, infusion 500 IU/kg per day (n=307) | patients with symptomatic pulmonary embolism | open Parallel groups Sample size: 301/307 Primary endpoint: recurrent thromboembolism, major bleeding, and death FU duration: 3 mo | | Campbell, 1998 | Tinzaparin, 175 IU/kg once daily, 5 days (n=6) vs. Unfractioned heparin: bolus 5000 IU, infusion 1400 IU/h (n=10) | Symptomatic PE | open Parallel groups Sample size: 6/10 Primary endpoint: FU duration: 3 mo |
|
| thrombosis prevention | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Lassen, 1991 | vs placebo | Deep vein thrombosis 0.68 [0.46; 1.00] | | all cause death 1.13 [0.07; 17.86] asymptomatic proximal DVT 0.72 [0.46; 1.10] | | Bergqvist [42] | vs placebo | | | all cause death 0.00 [0.00; NaN] total bleeding ∞ [NaN; ∞] major Bleeding ∞ [NaN; ∞] Pulmonary embolism 0.00 [0.00; NaN] Asymptomatic Deep vein thrombosis 0.35 [0.10; 1.20] wound hematoma NaN [NaN; NaN] | | vs placebo | | | | | Jorgensen, 2002 | vs placebo | | | proximal deep vein thrombosis 0.00 [0.00; NaN] PE NaN [NaN; NaN] distal DVT 0.63 [0.30; 1.31] VTE (symptomatic or asymptomatic) 0.59 [0.29; 1.23] symptomatic VTE NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Lassen, 1991 | tinzaparin 50/kg x1 +elastic stockings (n=105) vs. Placebo+elastic stockings (n=105) | Elective hip | double blind Sample size: 105/105 Primary endpoint: FU duration: 8-10 days | | Bergqvist [42] | Tinzaparin 3500 anti-Xa units (n=39) vs. Placebo (n=41) | | Blind Parallel groups Sample size: 39/41 Primary endpoint: FU duration: | | Leizorovicz, 1991 | Tinzaparin 2500 and 3500 anti Xa units (n=861) vs. UFH 10 000 units (n=429) | Abdominothoracic and gynaecological surgery | Blind Sample size: 861/429 Primary endpoint: FU duration: | | Jorgensen, 2002 | Tinzaparin 3500 IU (n=99) vs. no prophylaxis (n=106) | patients over 18 years of age with planned plaster cast on a lower extremity of at least 3 weeks | open, assessor-blinded Parallel groups Sample size: 99/106 Primary endpoint: FU duration: 38 days |
|
| venous thrombosis | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hull et al , 1992 | vs unfractionated heparin | Short term haemorrhage 0.09 [0.01; 0.72] | | all cause death 0.49 [0.24; 1.02] Recurrent thromboembolic event 0.41 [0.16; 1.04] | | Hull, 2006 | vs unfractionated heparin | | | All-cause mortality 1.05 [0.60; 1.85] Major hemorrhage 1.00 [0.36; 2.75] Recurrent DVT/DVTextension (total) 0.44 [0.19; 1.02] Thrombocytopenia 1.50 [0.44; 5.15] death at 3 months 1.05 [0.60; 1.85] | | Hull, 2002 | vs unfractionated heparin | | | VTE during follow-up after active anticoagulant treatment 1.00 [0.50; 2.01] VTE during active anticoagulant treatment 0.76 [0.40; 1.43] | | Romera, 2009 | vs unfractionated heparin | DVT (recurrent) 0.21 [0.05; 0.92] | | bleeding 0.34 [0.04; 3.24] VTE at the end of trial 0.47 [0.19; 1.20] VTE during follow-up after active anticoagulant treatment 0.17 [0.02; 1.40] VTE during active anticoagulant treatment 0.73 [0.24; 2.24] PE 1.37 [0.31; 5.98] |
| Trial | Treatments | Patients | Method |
|---|
| Hull et al , 1992 | Tinzaparin Subcutaneous once daily for >= Days, 175 U/kg BID (n=213) vs. unfractionated heparin intravenous APPTx2-3 (n=219) | | Sample size: 213/219 Primary endpoint: FU duration: 3 Months | | Hull, 2006 | Tinzaparin 175 antiXa/kg SQ daily for 12 weeks (n=-9) vs. UFH for 5 days followed by vitamin K antagonist (target
INR 2-3) for 12 weeks (n=-9) | patients with cancer (solid or hematological) with proximal DVT with or without PE and with a minimum life expectancy of 3 months imag | outcome assessment blinded Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 3 months | | Hull, 2002 | LMWH, 175 IU/kg qd followed by Tinzaparin 175 IU/kg qd (n=369) vs. UFH 5 d, followed by UFH therapeutic APTT followed by Warfarin target INR 2-3 (n=368) | patients with objective diagnosis of DVT by Venography/compression ultrasonography | open Sample size: 369/368 Primary endpoint: FU duration: 9 mo | | Romera, 2009 | tinzaparin SC 175 IU anti-Xa per kg once daily for 6 months (n=119) vs. acenocoumarol for target INR 2-3 for 6 months after initial LMWH (until INR 2-3) (n=122) | patients with symptomatic proximal DVT of the lowerlimbs confirmed by compression duplex ultrasound scan | open Parallel groups Sample size: 119/122 Primary endpoint: symptomatic recurrent venous thromboembolism FU duration: 12 months |
|
