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

NCT01046903

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female patient, undergoing major orthopedic surgery

- At least 18 years old

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
Official Title An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
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.
Detailed Description All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The adult population (women and men) after major orthopedic surgery.
Condition Venous Thromboembolism
Intervention Drug: Fragmin® (Dalteparin Sodium)
Administered per prescribing physician
Study Groups/Cohorts 1
Intervention: Drug: Fragmin® (Dalteparin Sodium)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 3, 2012)
503
Original Estimated Enrollment
 (submitted: January 11, 2010)
600
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01046903
Other Study ID Numbers A6301085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2012