Bone SarcomaNCT00525057
Dalteparin in Preventing DVT in Participants With Cancer
A study testing Dalteparin in people with Bone Sarcoma and Femur Fracture, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Bone Sarcoma, Femur Fracture, Lymphoma
- What is being tested?
- Dalteparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2006to 19 Jun 2020
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GROUP A
- Metastatic disease, myeloma, lymphoma.
- Pathologic fracture or impending pathologic fracture of the femur.
- Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
- GROUP B
- Primary sarcoma of bone or soft tissue of the lower extremity.
- T2 tumor (> 5 cm by < 20 cm).
- Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
Who cannot join
- Presence of DVT on pre-operative screening ultrasound study.
- Massive tumor (> 20 cm in greatest dimension).
- Amputation of the affected leg as treatment of tumor.
- Estimated blood loss > 2 liters during surgery.
- Surgical drain output > 500 cc of bloody fluid during first 8 hours.
- International normalized ratio (I.N.R.) > 1.3 pre-operatively or > 1.5 post-operatively.
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- Platelet count < 100,000 either pre-operatively or post-operatively.
- Indwelling post-operative epidural catheter for pain control.
- History of underlying bleeding disorder, such as hemophilia.
- History of adverse reaction to heparin such as heparin-induced thrombocytopenia.
- Severe liver or renal insufficiency.
- History of hypertensive or diabetic retinopathy.
- History of gastro-intestinal bleeding within 12 months.
- Treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), low molecular weight heparin (LMWH) or other anti-coagulants for conditions.
- History of stroke.
- Women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin [hCG]) at the time of pre-operative evaluation (within 7 days of surgery).
- Women who are breastfeeding.
- Hemoglobin < 8.0 g/dL.
- Platelet count < 100,000/L.
- Alanine aminotransferase > 100 IU/L.
- Aspartate aminotransferase > 100 IU/L.
- Direct bilirubin > 0.5mg/dL.
- Serum creatinine > 2.0 mg/dL.
- Patients taking COX-2 inhibitors.
- Patients who have fragmented mechanical heart valves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Bone Sarcoma, Femur Fracture, Lymphoma, Metastatic Neoplasm, Pathologic Fracture, Plasma Cell Myeloma
- Being tested
- Dalteparin
- Medical subject headings
- Bone Neoplasms, Femoral Fractures, Lymphoma, Neoplasm Metastasis, Fractures, Spontaneous, Multiple Myeloma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalteparinDrug
Given SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dalteparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after surgery
Secondary outcomes (2)
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.
Measured: 4 weeks after surgery
Post-Operative Blood Transfusion
The volume of packed red blood cell transfusion in the post-operative period
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study start7 Jul 2006
- Primary completion19 Jun 2020
- Study completion19 Jun 2020
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 Bone SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick Lin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525057
- Sponsor's protocol ID
- 2004-0743
- Other IDs
- NCI-2018-01848, 2004-0743
- Status last verified
- Dec 2020
- First submitted
- 4 Sep 2007
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
- ClinicalTrials.gov ID
- NCT00525057
- Acronym / sponsor ID
- 2004-0743
- Conditions
- Bone Sarcoma, Femur Fracture, Lymphoma, Metastatic Neoplasm, Pathologic Fracture, Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jul 2006 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dalteparin) | Experimental | Drug: DalteparinParticipants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- GROUP A
- Metastatic disease, myeloma, lymphoma.
- Pathologic fracture or impending pathologic fracture of the femur.
- Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
- GROUP B
Key exclusion criteria (25 listed)
- Presence of DVT on pre-operative screening ultrasound study.
- Massive tumor (> 20 cm in greatest dimension).
- Amputation of the affected leg as treatment of tumor.
- Estimated blood loss > 2 liters during surgery.
- Surgical drain output > 500 cc of bloody fluid during first 8 hours.
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 |
|---|---|---|
| DalteparinGiven SC | Drug | Treatment (dalteparin) |
Primary outcome
Number of Participants With Post-operative Wound Complications
Time frame: 4 weeks after surgery
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
2 secondary outcomes
Number of Participants With Occurrence of Venous Thromboembolism
Time frame: 4 weeks after surgery
Post-Operative Blood Transfusion
Time frame: 4 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Patrick Lin principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dalteparin in people with Bone Sarcoma and Femur Fracture, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 inclusion and 25 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 22 Jan 2021). 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?
Number of Participants With Post-operative Wound Complications (time frame: 4 weeks after surgery). 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 22 Jan 2021.