Trial Outcomes & Findings for Thrombelastography Based Dosing of Enoxaparin (NCT NCT00990236)
NCT ID: NCT00990236
Last Updated: 2020-04-03
Results Overview
An ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
Through study completion, assessed up to 120 days post randomization
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Exoxaparin 30 mg BID
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
96
|
|
Overall Study
COMPLETED
|
89
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exoxaparin 30 mg BID
n=89 Participants
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
n=96 Participants
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
n=89 Participants
|
48.5 years
n=96 Participants
|
46.0 years
n=185 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=89 Participants
|
25 Participants
n=96 Participants
|
65 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=89 Participants
|
71 Participants
n=96 Participants
|
120 Participants
n=185 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
89 participants
n=89 Participants
|
96 participants
n=96 Participants
|
185 participants
n=185 Participants
|
PRIMARY outcome
Timeframe: Through study completion, assessed up to 120 days post randomizationAn ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.
Outcome measures
| Measure |
Exoxaparin 30 mg BID
n=89 Participants
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
n=96 Participants
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
|---|---|---|
|
Development of Deep Vein Thrombosis (DVT)
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through study completion, assessed up to 120 days post randomizationAn increase in bleeding complications will be assessed daily during hospitalization
Outcome measures
| Measure |
Exoxaparin 30 mg BID
n=89 Participants
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
n=96 Participants
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
|---|---|---|
|
Incidence of Bleeding Complications
|
5 Participants
|
13 Participants
|
Adverse Events
Exoxaparin 30 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Enoxaparin Dose Adjusted Based on TEG
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Exoxaparin 30 mg BID
n=89 participants at risk
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
n=96 participants at risk
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/89 • Adverse event data was collected for a period up to 120 days.
|
1.0%
1/96 • Number of events 1 • Adverse event data was collected for a period up to 120 days.
|
Other adverse events
| Measure |
Exoxaparin 30 mg BID
n=89 participants at risk
standard dose enoxaparin thromboprophylaxis (30 mg twice daily)
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
Enoxaparin Dose Adjusted Based on TEG
n=96 participants at risk
enoxaparin dose modified based on TEG results
Dose-adjusted Lovenox based on TEG: Lovenox doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R \< 1.0 min - increase dose by 10 mg BID; delta-R \>/= 1.0 min and \</= 2.0 min - no change; delta-R \> 2.0 min - decrease dose by 10 mg BID.
|
|---|---|---|
|
Vascular disorders
Superficial venous thrombosis
|
1.1%
1/89 • Number of events 1 • Adverse event data was collected for a period up to 120 days.
|
1.0%
1/96 • Number of events 1 • Adverse event data was collected for a period up to 120 days.
|
Additional Information
Samantha Underwood, Research Manager
Oregon Health & Science University
Phone: 503-494-8481
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place