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Nonsteroidal Anti-inflammatory Drug
Aspirin vs LMWH for Blood Clot Prevention in Orthopaedic Cancer Surgery
Phase 4
Waitlist Available
Led By Santiago A Lozano-Calderon, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with metastatic osseous disease of the lower extremities or pelvis treated with specific surgical methods
Patients with primary bone sarcomas of the lower extremities or pelvis treated with specific surgical methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Awards & highlights
Study Summary
This trial aims to compare the rates of VTE between patients taking aspirin and those taking LMWH after pelvic/lower extremity orthopaedic surgery for cancer.
Who is the study for?
This trial is for adults with bone or soft tissue sarcomas in the lower body who are undergoing certain surgeries. It's not for those unable to consent, pregnant, needle-phobic, with a history of blood clots or allergies to study drugs, IVC filter presence, known clotting disorders (except cancer), on full-strength aspirin or other anticoagulants pre-surgery.Check my eligibility
What is being tested?
The trial compares Aspirin (325mg) and Enoxaparin (a low molecular weight heparin) as methods to prevent blood clots after orthopaedic surgery for patients with pelvic/lower extremity cancers. The goal is to see which drug better prevents postoperative VTE.See study design
What are the potential side effects?
Possible side effects include bleeding risks and hematoma formation due to the blood-thinning nature of both Aspirin and Enoxaparin. There may also be local reactions at injection sites for Enoxaparin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery for bone metastasis in my legs or pelvis.
Select...
I had surgery for bone cancer in my legs or pelvis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Venous thromboembolism
Secondary outcome measures
Complication requiring return to operating room
Early chemoprophylaxis stop
Hematoma formation
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: LMWH for Soft Tissue SarcomaExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
Group II: LMWH for Primary Bone TumorExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
Group III: LMWH for Metastatic DiseaseExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis
Group IV: ASA for Soft Tissue SarcomaExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis
Group V: ASA for Primary Bone TumorExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis
Group VI: ASA for Metastatic DiseaseExperimental Treatment1 Intervention
Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 325mg
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,609 Previous Clinical Trials
11,468,893 Total Patients Enrolled
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Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,008,902 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
10,000 Patients Enrolled for Deep Vein Thrombosis
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,196,921 Total Patients Enrolled
6 Trials studying Deep Vein Thrombosis
1,736 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot give myself injections.I have a diagnosed condition that causes abnormal blood clotting.I take 325 mg of aspirin daily before surgery.I cannot take blood thinners.I have had surgery for bone metastasis in my legs or pelvis.I cannot give consent myself due to a mental condition.I have a history of blood clots.You are afraid of needles.I am allergic to one of the drugs used in this study.You have a filter in your large vein called the inferior vena cava.I had surgery for bone cancer in my legs or pelvis.I have a soft tissue sarcoma in my leg or pelvis and am receiving specific treatments.I am taking blood thinners other than low-dose aspirin for surgery.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ASA for Metastatic Disease
- Group 2: LMWH for Soft Tissue Sarcoma
- Group 3: ASA for Soft Tissue Sarcoma
- Group 4: LMWH for Primary Bone Tumor
- Group 5: ASA for Primary Bone Tumor
- Group 6: LMWH for Metastatic Disease
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can be ameliorated by Enoxaparin 40Mg/0.4mL Prefilled Syringe?
"The Enoxaparin 40Mg/0.4mL Prefilled Syringe is a popular remedy for pain management and has also been effective in ameliorating the severity of conditions, such as myocardial infarction, catarrh, and general surgery."
Answered by AI
Is this clinical research a pioneering endeavor?
"Since 2005, Enoxaparin 40Mg/0.4mL Prefilled Syringe has been the subject of research and study with its initial trial taking place in that same year under Abbott sponsorship. After a successful first endeavour involving 15480 participants, Phase 4 drug approval was granted for this medication. Currently there are 186 trials being conducted all over the globe; spanning 1435 cities across 58 nations."
Answered by AI
What effects can be anticipated from utilizing Enoxaparin 40Mg/0.4mL Prefilled Syringe?
"Our team assigned a score of 3, indicating that Enoxaparin 40Mg/0.4mL Prefilled Syringe is safe for use due to its approval in the fourth phase trial."
Answered by AI
Are there any opportunities for enrolling in this investigation currently available?
"According to the information listed on clinicaltrials.gov, this medical study has ceased recruitment of new candidates as of April 6th 2022. Although it is not actively recruiting at this moment, there are still 791 other trials openly accepting participants."
Answered by AI
How many participants are engaging in this trial?
"This research trial is not currently recruiting participants. It was first posted on February 16th 2018 and last edited April 6th 2022. Alternatively, there are other studies with venous thromboembolism that need volunteers (605), as well as trials for Enoxaparin 40Mg/0.4mL Prefilled Syringe requiring enrolment (186)."
Answered by AI
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