An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01046903
First received: January 4, 2010
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

The objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.


Condition Intervention
Venous Thromboembolism
Drug: Fragmin® (Dalteparin Sodium)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Physician's Assessment of Efficacy of Treatment [ Time Frame: Baseline up to Week 5 ] [ Designated as safety issue: No ]
    Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.


Enrollment: 503
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Fragmin® (Dalteparin Sodium)
Administered per prescribing physician

Detailed Description:

All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The adult population (women and men) after major orthopedic surgery.

Criteria

Inclusion Criteria:

  • Male or female patient, undergoing major orthopedic surgery
  • At least 18 years old

Exclusion Criteria:

  • Hypersensitivity to Fragmin or other low molecular weight heparins or unfractioned heparin;
  • History of heparin induced thrombocytopaenia type II
  • Acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage.
  • Serious coagulation disorder;
  • Septic endocarditis;
  • Injuries to and operations in the central nervous system, eye and ear within one month before orthopaedic surgery;
  • Spinal or epidural anesthesia or other procedures requiring spinal puncture and concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and Unstable coronary artery disease);
  • Patients with serum creatinine level > 150 umol/l;
  • Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy;
  • High probability that patient will not return to the centre for follow-up;
  • Patient on oral anticoagulation therapy in the last 7 days;
  • Ongoing anticoagulant therapy with other medications or non-pharmacologic therapy during the study period;
  • Weight less than 40 kg;
  • Simultaneous participation in another pharmacological study or receiving any investigational drug 30 days or less before surgery;
  • Pregnancy or breastfeeding;
  • Clinically significant hepatic dysfunction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046903

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01046903     History of Changes
Other Study ID Numbers: A6301085
Study First Received: January 4, 2010
Results First Received: January 3, 2012
Last Updated: February 24, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Pfizer:
observational prolonged thromboprophylaxis

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014