NCT00525057 · REGISTRY CONDITION SEARCH

Dalteparin in Preventing DVT in Participants With Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2021-01-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Post-operative Wound Complications

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outcome · POSTED

Number of Participants With Occurrence of Venous Thromboembolism

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outcome · POSTED

Post-Operative Blood Transfusion

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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). * Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction. Exclusion Criteria: * 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. * 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.
healthy Volunteers: false
minimum Age: 30 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
intervention Names
Drug: Dalteparin
label
Treatment (dalteparin)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (dalteparin)
description
Given SC
name
Dalteparin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

PREVENTION

Enrollment

count: 65
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
measure
Number of Participants With Post-operative Wound Complications
time Frame
4 weeks after surgery

secondary Outcomes

description
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.
measure
Number of Participants With Occurrence of Venous Thromboembolism
time Frame
4 weeks after surgery
description
The volume of packed red blood cell transfusion in the post-operative period
measure
Post-Operative Blood Transfusion
time Frame
4 weeks after surgery

Full study description

brief 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.
detailed Description: 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.

Source references