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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01848 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2004-0743 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well dalteparin works in preventing deep vein thrombosis (DVT) (blood clots) in participants with cancer. Dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.
PRIMARY OBJECTIVES:
I. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients.
II. To determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity.
OUTLINE:
Participants receive dalteparin subcutaneously (SC) once daily (QD) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (dalteparin) | Experimental | Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin | Drug | Given SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Wound Complications | Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma. | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Occurrence of Venous Thromboembolism | A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism. | 4 weeks after surgery |
| Post-Operative Blood Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Lin | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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A total of 65 participants enrolled into the trial. 15 participants did not meet entry criteria and were excluded.
Recruitment Period: July 2006 - December 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional (Dalteparin, Metastatic) | Received dalteparin 5000 units daily postop, patients with metastatic disease. |
| FG001 | Interventional (Dalteparin, Sarcoma) | Received dalteparin 5000 units daily postop, patients with primary sarcomas. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional (Dalteparin, Metastatic) | Received dalteparin 5000 units daily postop, patients with metastatic disease. |
| BG001 | Interventional (Dalteparin, Sarcoma) | Received dalteparin 5000 units daily postop, patients with primary sarcomas. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Post-operative Wound Complications | Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma. | Posted | Count of Participants | Participants | 4 weeks after surgery |
|
4 weeks after surgery
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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 | Interventional (Dalteparin, Metastatic) | Received dalteparin 5000 units daily postop, patients with metastatic disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lin, MD/Professor, Orthopaedic Oncology | UT MD Anderson Cancer Center | (713) 745-0088 | plin@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2009 | Dec 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D005264 | Femoral Fractures |
| D008223 | Lymphoma |
| D009362 | Neoplasm Metastasis |
| D005598 | Fractures, Spontaneous |
| D009101 | Multiple Myeloma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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The volume of packed red blood cell transfusion in the post-operative period |
| 4 weeks after surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor Location | Count of Participants | Participants |
|
| Tumor Type | Count of Participants | Participants |
|
| Surgery | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Occurrence of Venous Thromboembolism | A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism. | Posted | Count of Participants | Participants | 4 weeks after surgery |
|
|
|
| Secondary | Post-Operative Blood Transfusion | The volume of packed red blood cell transfusion in the post-operative period | Posted | Mean | 95% Confidence Interval | mL | 4 weeks after surgery |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 1 |
| 25 |
| EG001 | Interventional (Dalteparin, Sarcoma) | Received dalteparin 5000 units daily postop, patients with primary sarcomas. | 0 | 25 | 0 | 25 | 4 | 25 |
| Wound infection | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
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| D050723 |
| Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D002241 |
| Carbohydrates |