You are here

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

Last updated on November 10, 2019

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 Representative

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 city or zip code to find studies near you.

Based on your search, you may also be interested in

Venous Thromboembolism
NCT02464969
All Genders
0+
Years
Multiple Sites
Descriptive Information
Brief TitleAn Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
Official TitleAn Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
Brief SummaryThe 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 DescriptionAll patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe adult population (women and men) after major orthopedic surgery.
ConditionVenous Thromboembolism
InterventionDrug: Fragmin® (Dalteparin Sodium)
Administered per prescribing physician
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: January 3, 2012)
503
Original Estimated Enrollment
 (submitted: January 11, 2010)
600
Actual Study Completion DateFebruary 2011
Actual Primary Completion DateFebruary 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01046903
Other Study ID NumbersA6301085
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now