Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism

Sponsors

Lead Sponsor: Complejo Hospitalario Xeral-Calde

Collaborator: LEO Pharma

Source Complejo Hospitalario Xeral-Calde
Brief Summary

The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

Detailed Description

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin) administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis. To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.

Overall Status Completed
Start Date 2005-04-01
Completion Date 2009-02-01
Primary Completion Date 2009-01-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin 6 months
Secondary Outcome
Measure Time Frame
direct and indirect cost of each treatment regimen 6 months
Major haemorrhagic events 6 months
Enrollment 102
Condition
Intervention

Intervention Type: Drug

Intervention Name: tinzaparin

Description: tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months

Other Name: innohep

Intervention Type: Drug

Intervention Name: acenocoumarol

Description: acenocoumarol for 6 months

Arm Group Label: acenocoumarol

Other Name: vitamin K antagonist

Eligibility

Criteria:

Inclusion Criteria: - Symptomatic pulmonary embolism patients confirmed by: - High probability ventilation/perfusion lung scan according to the PIOPED criteria - Spiral chest computed tomography, or - Pulmonary arteriography - Aged 18 years or above, of either sex - The patient must provide signed informed consent - Patients will be agreed for receiving ambulatory anticoagulant treatment Exclusion Criteria: - Massive pulmonary embolism - Allergy to heparin, other components of Tinzaparin or acenocoumarol - Previous thrombocytopenia induced by heparin - Thrombocytopenia < 100000/mm3 - History/signs/symptoms of congenital bleeding disorder - Life expectancy less than 90 days - Unfractioned heparin anticoagulation for more than 36 hours prior enrollment - Inability to participate in the home tinzaparin program - Clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis - Hemoglobin lower than 7 g/dL or Creatinin > 3mg/dL - Cerebral-vascular accident - Cerebral, medullary and ophthalmological surgery

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility:
Pneumology Service. Hospital Clínico | Santiago de Compostela, A Coruña, 15706, Spain
Pneumology Service. Hospital Xeral Cies | Vigo, Pontevedra, 36204, Spain
Pneumology Service. Hospital do Meixoeiro | Vigo, Pontevedra, 36214, Spain
Pneumology Service | Lugo, 27004, Spain
Location Countries

Spain

Verification Date

2009-02-01

Responsible Party

Name Title: Pérez de Llano, Luis MD

Organization: Pneumology Service, Complejo Hospitalario Xeral-Calde

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: tinzaparin

Type: Experimental

Description: tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months

Label: acenocoumarol

Type: Active Comparator

Description: tinzaparin followed by acenocoumarol for 6 months

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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