You are here

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

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT01046903
Pfizer
Completed
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Venous Thromboembolism
NCT00952380
All Genders
0+
Years
Multiple Sites
Venous Thrombosis, Pulmonary Embolism, Intracranial Sinus Thrombosis
NCT01297348
Females
Venous Thromboembolism
NCT02464969
All Genders
0+
Years
Multiple Sites
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
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.
All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The adult population (women and men) after major orthopedic surgery.
Venous Thromboembolism
Drug: Fragmin® (Dalteparin Sodium)
Administered per prescribing physician
1
Intervention: Drug: Fragmin® (Dalteparin Sodium)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
503
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01046903
A6301085
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now