CompletedNCT00525057Updated Jan 22, 2021Results posted

Dalteparin in Preventing DVT in Participants With Cancer

An interventional study of Dalteparin in Bone Sarcoma, Femur Fracture and Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Jul 2006, registered Sep 2007).

Phase: Not applicable
Study type: Interventional
Enrollment: 65
Allocation: Not applicable
Ages: 30 Years and older
Sex: All

Study 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 the 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.

Conditions studied

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

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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 65 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

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Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 65 participants (actual)

Study arms

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

Interventions

DrugDalteparin
Given SC

What researchers measure

Primary outcomes

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.
Time frame: 4 weeks after surgery

Secondary outcomes

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.
Time frame: 4 weeks after surgery
Post-Operative Blood Transfusion
The volume of packed red blood cell transfusion in the post-operative period
Time frame: 4 weeks after surgery

Results

Posted Jan 22, 2021

Participant flow

Recruitment Period: July 2006 - December 2010

Participant flow — Overall Study
Milestone	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Started	25	25
Completed	25	25
Not completed	0	0

Outcome measures

PrimaryNumber of Participants With Post-operative Wound Complications

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

Time frame:: 4 weeks after surgery
Reported as:: Count of participants · Participants

Number of Participants With Post-operative Wound Complications
Participants	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Seroma	1	4
Wound Infection	0	3
Wound Dehiscence	0	1

SecondaryNumber 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.

Time frame:: 4 weeks after surgery
Reported as:: Count of participants · Participants

Number of Participants With Occurrence of Venous Thromboembolism
Participants	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Deep venous thrombosis	1	0
Pulmonary embolism	0	0

SecondaryPost-Operative Blood Transfusion

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

Time frame:: 4 weeks after surgery
Reported as:: Mean · mL

Post-Operative Blood Transfusion
mL	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Post-Operative Blood Transfusion	213 (0 to 685)	271 (0 to 2059)

Adverse events

Collected over 4 weeks after surgery. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Interventional (Dalteparin, Metastatic)	0/25 (0%)	1/25 (4%)	1/25 (4%)
Interventional (Dalteparin, Sarcoma)	0/25 (0%)	0/25 (0%)	4/25 (16%)

Most frequent serious events

Most frequent serious events
Event	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Thromboembolic eventVascular disorders	1/25	0/25

Most frequent other events

Most frequent other events
Event	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
SeromaSurgical and medical procedures	1/25	4/25
Wound infectionSurgical and medical procedures	0/25	3/25

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
<=18 years	0	0	0
Between 18 and 65 years	20	21	41
>=65 years	5	4	9

Sex: Female, Male
Sex: Female, Male(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Female	11	9	20
Male	14	16	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	25	25	50

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	0	0
More than one race	0	0	0
Unknown or Not Reported	25	25	50

Region of Enrollment
Region of Enrollment(participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
United States	25	25	50

Tumor Location
Tumor Location(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Femur/Thigh	22	15	37
Tibia/Calf	0	6	6
Popliteal	3	4	7

Tumor Type
Tumor Type(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Carcinoma	25	0	25
Sarcoma	0	25	25

Surgery
Surgery(Participants)	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Wide Excision Only	0	20	20
Segmental Reconstruction	19	5	24
Curettage, Internal Fixation	6	0	6

Study locations

1 site

M D Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Study documents

Protocol and statistical analysis plan · Aug 19, 2009

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00525057
Lead sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Sep 5, 2007
Start date: Jul 7, 2006
Primary completion: Jun 19, 2020
Completion: Jun 19, 2020
Results posted: Jan 22, 2021
Last update: Jan 22, 2021

Study contacts

Patrick Lin

principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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