Dalteparin in Preventing DVT in Participants With Cancer

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00525057
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 65
• Location: 1
• Arm: 1
• Actual Duration (Months): 167.4
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Sarcoma; Femur Fracture; Lymphoma; Metastatic Neoplasm; Pathologic Fracture; Plasma Cell Myeloma; Soft Tissue Sarcoma	Drug: Dalteparin	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
• Actual Study Start Date: Jul 7, 2006
• Actual Primary Completion Date: Jun 19, 2020
• Actual Study Completion Date: Jun 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; Given SC

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Post-operative Wound Complications [4 weeks after surgery]

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

Secondary Outcome Measures

1. Number of Participants With Occurrence of Venous Thromboembolism [4 weeks after surgery]

   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.

2. Post-Operative Blood Transfusion [4 weeks after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Patrick Lin, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 19, 2009

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00525057
• Other Study ID Numbers: 2004-0743; NCI-2018-01848; 2004-0743
• First Posted: Sep 5, 2007
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma; Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm Metastasis; Fractures, Bone; Femoral Fractures; Fractures, Spontaneous; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight

Study Results

Participant Flow

Recruitment Details	Recruitment Period: July 2006 - December 2010
Pre-assignment Detail	A total of 65 participants enrolled into the trial. 15 participants did not meet entry criteria and were excluded.

Arm/Group Title	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.	Received dalteparin 5000 units daily postop, patients with primary sarcomas.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)	Total
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.	Received dalteparin 5000 units daily postop, patients with primary sarcomas.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 80%	21 84%	41 82%
>=65 years	5 20%	4 16%	9 18%
Sex: Female, Male (Count of Participants)
Female	11 44%	9 36%	20 40%
Male	14 56%	16 64%	30 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	25 100%	25 100%	50 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	25 100%	25 100%	50 100%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%
Tumor Location (Count of Participants)
Femur/Thigh	22 88%	15 60%	37 74%
Tibia/Calf	0 0%	6 24%	6 12%
Popliteal	3 12%	4 16%	7 14%
Tumor Type (Count of Participants)
Carcinoma	25 100%	0 0%	25 50%
Sarcoma	0 0%	25 100%	25 50%
Surgery (Count of Participants)
Wide Excision Only	0 0%	20 80%	20 40%
Segmental Reconstruction	19 76%	5 20%	24 48%
Curettage, Internal Fixation	6 24%	0 0%	6 12%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.	Received dalteparin 5000 units daily postop, patients with primary sarcomas.
Measure Participants	25	25
Seroma	1 4%	4 16%
Wound Infection	0 0%	3 12%
Wound Dehiscence	0 0%	1 4%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.	Received dalteparin 5000 units daily postop, patients with primary sarcomas.
Measure Participants	25	25
Deep venous thrombosis	1 4%	0 0%
Pulmonary embolism	0 0%	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional (Dalteparin, Metastatic)	Interventional (Dalteparin, Sarcoma)
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.	Received dalteparin 5000 units daily postop, patients with primary sarcomas.
Measure Participants	25	25
Mean (95% Confidence Interval) [mL]	213	271

Adverse Events

Time Frame	4 weeks after surgery
Arm/Group Title	Interventional (Dalteparin, Metastatic)		Interventional (Dalteparin, Sarcoma)
Arm/Group Description	Received dalteparin 5000 units daily postop, patients with metastatic disease.		Received dalteparin 5000 units daily postop, patients with primary sarcomas.
All Cause Mortality
	Interventional (Dalteparin, Metastatic)		Interventional (Dalteparin, Sarcoma)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Interventional (Dalteparin, Metastatic)		Interventional (Dalteparin, Sarcoma)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/25 (0%)
Vascular disorders
Thromboembolic event	1/25 (4%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Interventional (Dalteparin, Metastatic)		Interventional (Dalteparin, Sarcoma)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		4/25 (16%)
Surgical and medical procedures
Seroma	1/25 (4%)		4/25 (16%)
Wound infection	0/25 (0%)		3/25 (12%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.