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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fragmin® (Dalteparin Sodium) | Drug | Administered per prescribing physician |
|
| 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 |
Not provided
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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The adult population (women and men) after major orthopedic surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin Sodium | Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalteparin Sodium | Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalteparin Sodium | Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| 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 |
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary diagnosis | Number | Participants |
|
| Medical history | Number | Participants |
|
| Procedures After Primary Diagnosis | Number | Participants |
|
| Thromboembolic Disease Assessment | 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).Thromboembolic disease was assessed based on clinical examination only (presence of symptoms). | Number | Participants |
|
| Prior Surgery History | Number | Participants |
|
| Prior Study Medications | Number | Participants |
|
| Concomitant Study Medications | Number | Participants |
|
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline |
|
|
|
| Other Pre-specified | 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). | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Primary | 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. | The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| Other Pre-specified | Number of Participants Compliant With the Treatment | Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis. | Data was collected but not statistically summarized for analysis. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
| Other Pre-specified | 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. | The Safety Analysis Set included all those participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 5 |
|
|
|
| 26 |
| 503 |
| 46 |
| 503 |
| Gastritis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Device dislocation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Sciatic nerve palsy | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Skin sensitisation | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Device dislocation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Soft tissue inflammation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D002241 |
| Carbohydrates |
| Title | Measurements |
|---|
|
| 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) |
|
| Heart failure IV NYHA |
|
| Title | Measurements |
|---|---|
|
| Overall response (Poor) |
|
| Overall comfort (Excellent) |
|
| Overall comfort (Good) |
|
| Overall comfort (Fair) |
|
| Overall comfort (Poor) |
|
| Title | Measurements |
|---|
|
| Fair |
|
| Poor |
|
| Not reported |
|
| Title | Measurements |
|---|
|
| Fair |
|
| Poor |
|
| Not reported |
|
| Title | Measurements |
|---|---|
|
| Other |
|