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Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

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ClinicalTrials.gov Identifier: NCT01696760
Recruitment Status : Completed
First Posted : October 1, 2012
Results First Posted : July 4, 2014
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Mayerson, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Bone Metastases
Musculoskeletal Cancer
Soft Tissue Sarcoma
Thromboembolism
Interventions Drug: acetylsalicylic acid
Drug: enoxaparin
Device: PCD
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Period Title: Overall Study
Started 9 3
Completed 9 3
Not Completed 0 0
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD) Total
Hide Arm/Group Description

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Total of all reporting groups
Overall Number of Baseline Participants 9 3 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  88.9%
3
 100.0%
11
  91.7%
>=65 years
1
  11.1%
0
   0.0%
1
   8.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
Female
3
  33.3%
2
  66.7%
5
  41.7%
Male
6
  66.7%
1
  33.3%
7
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  11.1%
0
   0.0%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
  11.1%
1
  33.3%
2
  16.7%
More than one race
0
   0.0%
1
  33.3%
1
   8.3%
Unknown or Not Reported
7
  77.8%
1
  33.3%
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
  22.2%
2
  66.7%
4
  33.3%
Unknown or Not Reported
7
  77.8%
1
  33.3%
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 3 participants 12 participants
9 3 12
1.Primary Outcome
Title DVT Incident Rate
Hide Description This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Pulmonary Embolism Rate
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Development of Other Complications (Including Bleeding Complications)
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Readmission Rate to Hopsital
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Hematoma Formation
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Excessive Wound Drainage
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Death Rate
Hide Description [Not Specified]
Time Frame Up to 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description:

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Overall Number of Participants Analyzed 9 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Hide Arm/Group Description

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

All-Cause Mortality
Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Acetylsalicylic Acid and PCD) Arm II (Enoxaparin and PCD)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/3 (0.00%) 
Overall patient compliance for the study was low
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joel Mayerson, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-4420
Responsible Party: Joel Mayerson, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01696760     History of Changes
Other Study ID Numbers: OSU-10055
NCI-2012-00894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 27, 2012
First Posted: October 1, 2012
Results First Submitted: June 4, 2014
Results First Posted: July 4, 2014
Last Update Posted: December 5, 2018