TY - JOUR
T1 - Effects on thrombin generation of single injections of Hirulog® in patients with calf vein thrombosis
AU - Ginsberg, J. S.
AU - Nurmohamed, M. T.
AU - Gent, M.
AU - MacKinnon, B.
AU - Stevens, P.
AU - Weitz, J.
AU - Maraganore, J.
AU - Hirsh, J.
PY - 1994
Y1 - 1994
N2 - Study objective: To determine whether single injections of Hirulog, a direct thrombin inhibitor, can inhibit thrombin generation in patients with calf vein thrombosis and, if so, if the inhibition is sustained. Design: Phase II open label cohort study. Setting: Tertiary-care referral centres, university affiliated hospitals. Patients: 10 patients with venographically-demonstrated calf vein thrombosis. Intervention: Patients received a single injection of Hirulog, either 1.0 mg/kg subcutaneously or 0.6 mg/kg as a 15 min intravenous infusion. Prothrombin fragment (F1+2) levels, as an index of thrombin generation, were measured before as well as 6 h post- and 24 h post-Hirulog administration. Patients were followed with non-invasive tests to detect thrombus extension into the proximal veins. Results: There was a significant reduction in the levels of F1+2 with both regimens, 6 h after Hirulog. The F1+2 levels 24 h post-Hirulog showed a significant increase relative to the 6 h post-Hirulog results. One patient developed thrombus extension into the popliteal vein and was treated with conventional anticoagulants. Conclusion: The single injections of Hirulog used in the study produced incomplete and temporary suppression of F1+2. Complete and permanent inhibition of thrombin generation with Hirulog in patients with calf vein thrombosis may require higher doses, multiple subcutaneous injections and/or prolonged intravenous infusion.
AB - Study objective: To determine whether single injections of Hirulog, a direct thrombin inhibitor, can inhibit thrombin generation in patients with calf vein thrombosis and, if so, if the inhibition is sustained. Design: Phase II open label cohort study. Setting: Tertiary-care referral centres, university affiliated hospitals. Patients: 10 patients with venographically-demonstrated calf vein thrombosis. Intervention: Patients received a single injection of Hirulog, either 1.0 mg/kg subcutaneously or 0.6 mg/kg as a 15 min intravenous infusion. Prothrombin fragment (F1+2) levels, as an index of thrombin generation, were measured before as well as 6 h post- and 24 h post-Hirulog administration. Patients were followed with non-invasive tests to detect thrombus extension into the proximal veins. Results: There was a significant reduction in the levels of F1+2 with both regimens, 6 h after Hirulog. The F1+2 levels 24 h post-Hirulog showed a significant increase relative to the 6 h post-Hirulog results. One patient developed thrombus extension into the popliteal vein and was treated with conventional anticoagulants. Conclusion: The single injections of Hirulog used in the study produced incomplete and temporary suppression of F1+2. Complete and permanent inhibition of thrombin generation with Hirulog in patients with calf vein thrombosis may require higher doses, multiple subcutaneous injections and/or prolonged intravenous infusion.
UR - http://www.scopus.com/inward/record.url?scp=0027990521&partnerID=8YFLogxK
U2 - https://doi.org/10.1055/s-0038-1648907
DO - https://doi.org/10.1055/s-0038-1648907
M3 - Article
C2 - 7878625
SN - 0340-6245
VL - 72
SP - 523
EP - 525
JO - Thrombosis and haemostasis
JF - Thrombosis and haemostasis
IS - 4
ER -