Trial Outcomes & Findings for Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology (NCT NCT01696760)
NCT ID: NCT01696760
Last Updated: 2018-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
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 If patients refuse to wear the PCDs, they will be withdrawn from the study.
|
Arm II (Enoxaparin and PCD)
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 If patients refuse to wear the PCDs, they will be withdrawn from the study.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 Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
Baseline characteristics by cohort
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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 If patients refuse to wear the PCDs, they will be withdrawn from the study.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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 If patients refuse to wear the PCDs, they will be withdrawn from the study.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
n=12 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
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsThis 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.
Outcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
DVT Incident Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Pulmonary Embolism Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Development of Other Complications (Including Bleeding Complications)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Readmission Rate to Hopsital
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Hematoma Formation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Excessive Wound Drainage
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
Arm I (Acetylsalicylic Acid and PCD)
n=9 Participants
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.
|
Arm II (Enoxaparin and PCD)
n=3 Participants
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.
|
|---|---|---|
|
Death Rate
|
0 Participants
|
0 Participants
|
Adverse Events
Arm I (Acetylsalicylic Acid and PCD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Enoxaparin and PCD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joel Mayerson, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-4420
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place