Venous ThromboembolismNCT01046903
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
An observational study of Venous Thromboembolism, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Fragmin® (Dalteparin Sodium)
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The adult population (women and men) after major orthopedic surgery.
Who may be able to join
- Male or female patient, undergoing major orthopedic surgery
- At least 18 years old
Who cannot join
- 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;
Show all 16Show fewer
- 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.
About this study
Official title: 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.
Read the detailed description
All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study
- Conditions
- Venous Thromboembolism
- Being tested
- Fragmin® (Dalteparin Sodium)
- Keywords
- observational prolonged thromboprophylaxis
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragmin® (Dalteparin Sodium)Drug
Administered per prescribing physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Fragmin® (Dalteparin Sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046903
- Sponsor's protocol ID
- A6301085
- Status last verified
- Feb 2012
- First submitted
- 4 Jan 2010
- Last updated
- 27 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01046903
- Acronym / sponsor ID
- A6301085
- Conditions
- Venous Thromboembolism
- Keywords
- observational prolonged thromboprophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 13 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Fragmin® (Dalteparin Sodium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The adult population (women and men) after major orthopedic surgery.
Key inclusion criteria (2 listed)
- Male or female patient, undergoing major orthopedic surgery
- At least 18 years old
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fragmin® (Dalteparin Sodium)Administered per prescribing physician | Drug | 1 |
Primary outcome
Physician's Assessment of Efficacy of Treatment
Time frame: Baseline up to Week 5
Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Assessment of Efficacy of Treatment (time frame: Baseline up to Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.