Table 2 Summary of clinical efficacy outcomes by the Steering Committee
From: Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial
Patient number | Bleeding risk factors | Thrombotic risk factors | HIT | Baseline thrombosisa | New/extended thrombosis | Major bleeding | Bleeding | Death |
|---|---|---|---|---|---|---|---|---|
1 | Gastric ulcer; renal failure | Recent orthopedic surgery; obesity; vena cava filter | Confirmed | Yes x 2 | No | No | No | No |
2 | Antiplatelet treatment | - | Confirmed | No | No | No | No | No |
3 | Cardiac surgery; renal failure | AF | Confirmed | Yes | No | Yes, hematuria | No | Yes, cardiogenic shock |
4 | Antiplatelet treatment | Obesity; DVT; PE; lupus anticoagulant | Confirmed | Yes x 2 | Yes x 4 | No | No | No |
3 DVT extension | ||||||||
1 new | ||||||||
5 | Antiplatelet treatment; renal failure | Sepsis; AF | Confirmed | No | No | No | No | No |
6 | Acute renal failure; moderate hepatic cystosis | DVT; sepsis | Confirmed | Yes | No | No | No | No |
7 | Renal failure; cardiac insufficiency; liver insufficiency | DVT; PE | Not confirmed | Yes | No | No | No | Yes, congestive heart failure |
8b | Acute renal failure; hepatic insufficiency; gastric ulcer; abdominal surgery; overdose | Cancer; sepsis; PE | Not confirmed | Yes x 2 | Yes x 2 | No | Yes | Yes, MOF but after end of FU period |
2 new | ||||||||
9 | Digestive angiodysplasia; renal failure | AF; cardiac insufficiency | Confirmed | Yes | Yes, new-limb ischemia | No | No | No |
10 | - | Sepsis; DVT; PE | Confirmed | Yes x 2 | No | No | No | Yes, refractory hypoxemia due to ARDS |
11 | Abdominal and cardiac surgery | Cancer; cardiac surgery; sepsis | Confirmed | Yes x 2 | No | No | No | No |
12 | Hepatic impairment and cardiac surgery | Cardiac surgery | Confirmed | No | No | No | No | No |
13 | Acute kidney failure; intra-alveolar hemorrhage | Obesity; cardiac insufficiency; sepsis | Confirmed | Yes | No | No | No | No |
14c | Renal failure; hepatic insufficiency; cardiac surgery | Cardiac insufficiency; intra-aortic balloon pump; cardiac surgery | Confirmed | Yes x 2 | No | Yes, rectorrhagia | Yes, hematemesis | Yes, MOF and refractory shock |
15 | - | Arterial thrombosis; sepsis | Confirmed | Yes | Yes, new right internal jugular vein thrombosis, catheter-related | No | No | No |
16 | Renal failure; acute hepatic insufficiency | Cardiac insufficiency; AF; varicose vein | Not confirmed | No | No | No | No | No |
17 | Acute renal failure; vascular surgery | Obesity; AF; sepsis; arterial thrombosis | Confirmed | Yes | Yes | Yes, due to puncture of dialysis catheter | No | Yes, sepsis with MOF |
18 | Renal insufficiency; fissuring aneurysm | Suspected cancer; vascular surgery; arterial thrombosis; PE | Not confirmed | Yes x 2 | No | No | No | Yes, degradation of general condition complicated by per-renal azotemia |
19d | Renal insufficiency; aortic dissection surgery; antiplatelet therapy | Obesity; cardiac insufficiency; sepsis | Confirmed | No | No | No | No | No |
20 | Renal failure and cardiac surgery | Obesity; cardiac surgery; cardiac insufficiency | Confirmed | No | No | No | No | No |
Total | 14 yes | 5 yes | 3 x major | 2 x non major | 7 yes (1 died after end of FU period); all deaths due to underlying diseases |