N/A N=50 Prevention

Dalteparin in Preventing DVT in Participants With Cancer

Bone Sarcoma · Femur Fracture · Lymphoma · Metastatic Neoplasm · Pathologic Fracture

Bottom Line

View on ClinicalTrials.gov: NCT00525057 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Jan 2021

Primary outcome: Primary: Number of Participants With Post-operative Wound Complications — 1; 4; 0; 3 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dalteparin (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Post-operative Wound Complications	1; 4; 0; 3; 0; 1	—
SECONDARY Number of Participants With Occurrence of Venous Thromboembolism	1; 0; 0; 0	—
SECONDARY Post-Operative Blood Transfusion	213; 271	—

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.

Eligibility Criteria

Inclusion Criteria

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 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.
Platelet count 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00525057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.