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

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ataturk University
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Adults, age ≥ 18 years

• Patients who have signed the study informed consent form prior to initiation of any study-related procedure.

• Acute massive PE patients who require thrombolytic treatment.

Exclusion Criteria:

• Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission.

• Patients who received any anticoagulation medication prior to admission to the hospital.