Trial Outcomes & Findings for Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty (NCT NCT01809054)
NCT ID: NCT01809054
Last Updated: 2014-04-21
Results Overview
requiring transfusion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin
|
Pneumatic Compression Stockings Arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
|
Overall Study
COMPLETED
|
27
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Baseline characteristics by cohort
| Measure |
Arixtra Arm
n=27 Participants
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin
|
Pneumatic Compression Stockings Arm
n=22 Participants
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58 years
STANDARD_DEVIATION 14 • n=7 Participants
|
58 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksrequiring transfusion
Outcome measures
| Measure |
Arixtra Arm
n=27 Participants
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin
|
Pneumatic Compression Stockings Arm
n=22 Participants
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin
|
|---|---|---|
|
Blood Loss
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 weeksverified by ultrasound
Outcome measures
| Measure |
Arixtra Arm
n=27 Participants
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Arixtra
Aspirin
|
Pneumatic Compression Stockings Arm
n=22 Participants
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Aspirin
|
|---|---|---|
|
Deep Vein Thrombosis
|
0 participants
|
0 participants
|
Adverse Events
Arixtra Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pneumatic Compression Stockings Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place