Comparison of Low-Molecular-Weight Heparin (LMWH) and Unfractionated Heparin (UFH) in Combination With Thrombolytic Treatment of Acute Massive Pulmonary Thromboembolism

Summary

Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease, with an approximately 30% mortality rate without treatment. Treatment is important to reduce mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH \[4\]. Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic events and less major bleeding. Current guidelines recommend use of SC LMWH for most hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the setting of acute massive PE. The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the treatment of acute PE in combination with thrombolytic treatment.

Timeline

Start

2011-01

Primary completion

2013-12

Completion

2014-01

Publications

• Results Ucar EY, Araz O, Akgun M, Meral M, Kalkan F, Saglam L, Kaynar H, Gorguner AM. Low-molecular-weight heparin use with thrombolysis: is it effective and safe? Ten years' clinical experience. Respiration. 2013;86(4):318-23. doi: 10.1159/000346203. Epub 2013 Feb 9.
• Results Erkens PM, Prins MH. Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD001100. doi: 10.1002/14651858.CD001100.pub3.
• Results Jerjes-Sanchez C, Villarreal-Umana S, Ramirez-Rivera A, Garcia-Sosa A, Miguel-Canseco L, Archondo T, Reyes E, Garza A, Arriaga R, Castillo F, Jasso O, Garcia H, Bermudez M, Hernandez JM, Garcia J, Martinez P, Rangel F, Gutierrez J, Comparan-Nunez A. Improving adjunctive treatment in pulmonary embolism and fibrinolytic therapy. The role of enoxaparin and weight-adjusted unfractionated heparin. J Thromb Thrombolysis. 2009 Feb;27(2):154-62. doi: 10.1007/s11239-008-0192-3. Epub 2008 Jan 19.
• Ucar EY, Akgun M, Araz O, Tas H, Kerget B, Meral M, Kaynar H, Saglam L. Comparison of LMWH versus UFH for hemorrhage and hospital mortality in the treatment of acute massive pulmonary thromboembolism after thrombolytic treatment : randomized controlled parallel group study. Lung. 2015 Feb;193(1):121-7. doi: 10.1007/s00408-014-9660-z. Epub 2014 Oct 29.

Drugs

Indications

No indication recorded.