Trial Outcomes & Findings for Dalteparin in Preventing DVT in Participants With Cancer (NCT NCT00525057)
NCT ID: NCT00525057
Last Updated: 2021-01-22
Results Overview
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
4 weeks after surgery
Results posted on
2021-01-22
Participant Flow
Recruitment Period: July 2006 - December 2010
A total of 65 participants enrolled into the trial. 15 participants did not meet entry criteria and were excluded.
Participant milestones
| Measure |
Interventional (Dalteparin, Metastatic)
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dalteparin in Preventing DVT in Participants With Cancer
Baseline characteristics by cohort
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Tumor Location
Femur/Thigh
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Tumor Location
Tibia/Calf
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Tumor Location
Popliteal
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Tumor Type
Carcinoma
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Tumor Type
Sarcoma
|
0 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Surgery
Wide Excision Only
|
0 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Surgery
Segmental Reconstruction
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Surgery
Curettage, Internal Fixation
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after surgeryOur primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
Outcome measures
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Number of Participants With Post-operative Wound Complications
Seroma
|
1 Participants
|
4 Participants
|
|
Number of Participants With Post-operative Wound Complications
Wound Infection
|
0 Participants
|
3 Participants
|
|
Number of Participants With Post-operative Wound Complications
Wound Dehiscence
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryA 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.
Outcome measures
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Number of Participants With Occurrence of Venous Thromboembolism
Deep venous thrombosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Occurrence of Venous Thromboembolism
Pulmonary embolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after surgeryThe volume of packed red blood cell transfusion in the post-operative period
Outcome measures
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 Participants
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Post-Operative Blood Transfusion
|
213 mL
Interval 0.0 to 685.0
|
271 mL
Interval 0.0 to 2059.0
|
Adverse Events
Interventional (Dalteparin, Metastatic)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Interventional (Dalteparin, Sarcoma)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 participants at risk
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 participants at risk
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • 4 weeks after surgery
|
0.00%
0/25 • 4 weeks after surgery
|
Other adverse events
| Measure |
Interventional (Dalteparin, Metastatic)
n=25 participants at risk
Received dalteparin 5000 units daily postop, patients with metastatic disease.
|
Interventional (Dalteparin, Sarcoma)
n=25 participants at risk
Received dalteparin 5000 units daily postop, patients with primary sarcomas.
|
|---|---|---|
|
Surgical and medical procedures
Seroma
|
4.0%
1/25 • 4 weeks after surgery
|
16.0%
4/25 • 4 weeks after surgery
|
|
Surgical and medical procedures
Wound infection
|
0.00%
0/25 • 4 weeks after surgery
|
12.0%
3/25 • 4 weeks after surgery
|
Additional Information
Patrick Lin, MD/Professor, Orthopaedic Oncology
UT MD Anderson Cancer Center
Phone: (713) 745-0088
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place