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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Fragmin® (Dalteparin Sodium)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 503

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Week 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's Dosage Regimen	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.	Baseline up to Week 5
Number of Participants With Risk Factors	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.	Baseline
Number of Participants With Thromboembolism	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).	Baseline up to Week 5
Number of Participants With Bleeding	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.	Baseline up to Week 5
Participant's Global Evaluation of Treatment	Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.	Baseline up to Week 5
Physician's Assessment of Tolerability of Treatment	Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.	Baseline up to Week 5
Administration Schedule of Treatment	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.	Baseline up to Week 5
Number of Participants Compliant With the Treatment	Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.	Baseline up to Week 5
Number of Participants With Hematoma	Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.	Baseline up to Week 5

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Estimate): February 27, 2012
• Last Update Submitted That Met QC Criteria: February 24, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: observational prolonged thromboprophylaxis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: A6301085