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

NCT01046903 | Completed Results

• 1 other identifier: A6301085
• Study Type: observational
• Target: 503
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Venous Thromboembolism

Keywords

observational prolonged thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• Physician's Assessment of Efficacy of Treatment

  Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.

  Baseline up to Week 5

Other Outcomes (9)

• Participant's Dosage Regimen

  Baseline up to Week 5

• Number of Participants With Risk Factors

  Baseline

• Number of Participants With Thromboembolism

  Baseline up to Week 5

Study Arms (1)

1

Drug: Fragmin® (Dalteparin Sodium)

Interventions

Fragmin® (Dalteparin Sodium) DRUG

Administered per prescribing physician

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 12, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 27, 2012
• Results First Posted: February 13, 2012

Record last verified: 2012-02