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

• ClinicalTrials.gov Identifier: NCT01046903
• Recruitment Status: Completed
• First Posted: January 12, 2010
• Results First Posted: February 13, 2012
• Last Update Posted: February 27, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Venous Thromboembolism	Drug: Fragmin® (Dalteparin Sodium)

Detailed Description:

All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study

Study Design

• Study Type: Observational
• Actual Enrollment: 503 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
• Study Start Date: March 2010
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Groups and Cohorts

Group/Cohort	Intervention/treatment
1	Drug: Fragmin® (Dalteparin Sodium); Administered per prescribing physician

Outcome Measures

Primary Outcome Measures :

1. 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.

Other Outcome Measures:

1. Participant's Dosage Regimen [ Time Frame: Baseline up to Week 5 ]
   Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.
2. Number of Participants With Risk Factors [ Time Frame: Baseline ]
   Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.
3. Number of Participants With Thromboembolism [ Time Frame: Baseline up to Week 5 ]
   Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).
4. Number of Participants With Bleeding [ Time Frame: Baseline up to Week 5 ]
   Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding.
5. Participant's Global Evaluation of Treatment [ Time Frame: Baseline up to Week 5 ]
   Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.
6. Physician's Assessment of Tolerability of Treatment [ Time Frame: Baseline up to Week 5 ]
   Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.
7. Administration Schedule of Treatment [ Time Frame: Baseline up to Week 5 ]
   Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.
8. Number of Participants Compliant With the Treatment [ Time Frame: Baseline up to Week 5 ]
   Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.
9. Number of Participants With Hematoma [ Time Frame: Baseline up to Week 5 ]
   Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01046903
• Other Study ID Numbers: A6301085
• First Posted: January 12, 2010
• Results First Posted: February 13, 2012
• Last Update Posted: February 27, 2012
• Last Verified: February 2012

Keywords provided by Pfizer:

observational prolonged thromboprophylaxis

Additional relevant MeSH terms:

Thrombosis; Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action