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Dalteparin in Preventing DVT in Participants With Cancer

Primary Purpose

Bone Sarcoma, Femur Fracture, Lymphoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dalteparin

About this trial

This is an interventional prevention trial for Bone Sarcoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (dalteparin)

Arm Description

Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Post-Operative Blood Transfusion

The volume of packed red blood cell transfusion in the post-operative period

Full Information

NCT ID

NCT00525057

First Posted

September 4, 2007

Last Updated

December 31, 2020

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00525057

Brief Title

Dalteparin in Preventing DVT in Participants With Cancer

Official Title

DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 7, 2006 (Actual)

Primary Completion Date

June 19, 2020 (Actual)

Study Completion Date

June 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Sarcoma, Femur Fracture, Lymphoma, Metastatic Neoplasm, Pathologic Fracture, Plasma Cell Myeloma, Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (dalteparin)

Arm Type

Experimental

Arm 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 Type

Drug

Intervention Name(s)

Dalteparin

Intervention Description

Given SC

Primary Outcome Measure Information:

Title

Number of Participants With Post-operative Wound Complications

Description

Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.

Time Frame

4 weeks after surgery

Secondary Outcome Measure Information:

Title

Number of Participants With Occurrence of Venous Thromboembolism

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.

Time Frame

4 weeks after surgery

Title

Post-Operative Blood Transfusion

Description

The volume of packed red blood cell transfusion in the post-operative period

Time Frame

4 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Lin

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center Website

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Dalteparin in Preventing DVT in Participants With Cancer

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