Clinical trial NCT00711308: Tinzaparin in the Treatment of the Acute Pulmonary Embolism
Official title: Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pulmonary Embolism
Keywords: pulmonary embolism
low molecular weight heparin
vitamin K antagonist
Longterm
Lead sponsor: Complejo Hospitalario Xeral-Calde
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2008-07-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
timeFrame: 6 months
Secondary outcomes:
measure: direct and indirect cost of each treatment regimen
timeFrame: 6 months
measure: Major haemorrhagic events
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Pneumology Service. Hospital Clínico
state: A Coruña
city: Vigo
country: Spain
facility: Pneumology Service. Hospital Xeral Cies
state: Pontevedra
city: Vigo
country: Spain
facility: Pneumology Service. Hospital do Meixoeiro
state: Pontevedra
city: Lugo
country: Spain
facility: Pneumology Service
Study officials:
affiliation: Complejo Hospitalario Xeral Calde (Lugo)
name: Luis Pérez de Llano, MD
role: STUDY_CHAIR
affiliation: Complejo Hospitalario Xeral Calde (Lugo)
name: Alejandro Veres Racamonde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Meixoeiro (Vigo)
name: Manuel Núnez Delgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Santiago
name: Ana Palacios Bartolomé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Xeral (Vigo)
name: Virginia Leiro Fernández, MD
role: PRINCIPAL_INVESTIGATOR
References: