I was just looking around to see how frequently DVT occurs in HD patients following surgery, pregnancy or injury. It is pretty common as you can see below. This makes me feel much more confident about FDA approval since we have already 14 patients from the European study that didn't show symptomatic DVT. I do recall that ultrasound scans did find some evidence of some DVT in 2 patients, but this cleared up following continued treatment. Given the the FDA will be scoring sympomatic DVT, we already are half-way to approval. I know you have brought this up several times already Dew, but I enjoyed repeating it now
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Arteriosclerosis, Thrombosis, and Vascular Biology. 1996;16:742-748.
Thrombotic Risk in Hereditary Antithrombin III, Protein C, or Protein S Deficiency
A Cooperative, Retrospective Study
Thrombotic Risk During and After Pregnancy
Twenty-five females with AT-III, 23 with PC, and 23 with PS deficiency had been pregnant at least once. The average number of pregnancies was significantly different among the three deficiency states: 2.2 for AT-III–deficient females; 2.8 for PC-deficient females; and 3.6 for PS-deficient females. In Table 5 data on thrombotic events during and after pregnancy are shown. Twenty-nine pregnancies were excluded because either heparin was administered prophylactically or the patients were not able to give exact information on the clinical history. Development of DVT and/or PE during pregnancy was frequent in AT-III–deficient females (40% of pregnancies).
Thrombotic Risk After Injury
Information on 122 injuries was available, and in 21 of these events the patients either received or did not know if they had received thromboprophylaxis; these events were therefore excluded from further evaluation. The injuries were categorized as those of the leg with cast fixation (55 events), the arm with cast fixation (26 events), and other (20 events; mostly soft-tissue trauma to the leg). After 17 of 101 injuries (17%) thromboembolism occurred. The age of patients when injury was followed by thrombosis was significantly higher (mean, 28.5 years) than that of those in whom injury was not followed by thrombosis (mean, 18.5 years; P=.0017). The youngest age at which posttraumatic thrombosis occurred in AT-III and PS deficiencies was 14 years and in PC deficiency 19 years. None of the 26 patients with cast fixation of the arm developed thrombosis. There was a relatively sharp distinction regarding age and thrombotic risk during/after cast fixation of the leg (Table 4). Whereas none of the 21 injuries in patients younger than 14 years was complicated by venous thrombosis, venous thromboembolism occurred after one third of injuries in patients older than 14 years (and in 5 events before the age of 20 years). In 5 patients thromboembolism occurred after soft-tissue trauma to the leg without cast fixation.
Table 4. Risk of Postoperative/Posttraumatic Thrombosis Without Prophylaxis
Age <14 y Age >14 y
After appendectomy
AT-III 0/8 2/9
PC 0/11 1/3
PS 0/6 2/6
Total 0/25 5/18
During/after cast fixation (leg)
AT-III 0/4 6/14
PC 0/8 5/10
PS 0/9 2/10
Total 0/21 13/34
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