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

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ClinicalTrials.gov Identifier: NCT01956955
Recruitment Status : Unknown
Verified October 2013 by Elif Yilmazel Ucar, Ataturk University.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Elif Yilmazel Ucar, Ataturk University

Brief 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.


Condition or disease Intervention/treatment Phase
This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Drug: enoxaparin ,alteplase, unfractionated heparin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: enoxaparin and alteplase
After alteplase therapy , 4-6 hour later, activated partial thromboplastin time (APTT) was checked. According to initial SC LMWH use time, fixed dose SC LMWH, enoxaparin, was administered subcutaneous every 12 hours.
Drug: enoxaparin ,alteplase, unfractionated heparin
Active Comparator: Unfractionated heparin and alteplase
After thrombolytic treatment, a bolus of 10 mg of alteplase followed by 90 mg over 2-h infusion, patients either administered a constant heparin infusion (18 U/Kg per hour) adjusted to maintain an activated partial thromboplastin time of 46-70 s.
Drug: enoxaparin ,alteplase, unfractionated heparin



Primary Outcome Measures :
  1. The primary aim of the study is to compare the major hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. [ Time Frame: 7 day ]
    Number of patients with adverse events


Secondary Outcome Measures :
  1. The secondary aim of the study is to compare the minor hemorrhage risk between the use of LMWH plus thrombolytic treatment and UFH plus thrombolytic in the treatment of acute massive PE. [ Time Frame: 7 day ]
    Number of patients with adverse events


Other Outcome Measures:
  1. Mortality [ Time Frame: 5 day ]
    Number of patients with mortality



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956955


Locations
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Turkey
Ataturk University Faculty of Medicine Pulmonary Disease Department Recruiting
Erzurum, Turkey, 25240
Contact: Elif Yilmazel Ucar, Assit prof    0090442 344 7447    eucar1979@yahoo.com   
Principal Investigator: Elif Yilmazel Ucar, Assit prof         
Sponsors and Collaborators
Ataturk University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elif Yilmazel Ucar, Chest physician, Ataturk University
ClinicalTrials.gov Identifier: NCT01956955     History of Changes
Other Study ID Numbers: Massive Pulmonary Embolism
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Tissue Plasminogen Activator
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action