Trial Outcomes & Findings for Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients (NCT NCT03251963)
NCT ID: NCT03251963
Last Updated: 2020-07-08
Results Overview
Number of patients with in range initial peak Xa level
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
36 hours
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Fixed Dose Enoxaparin
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
|
Overall Study
COMPLETED
|
56
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Fixed Dose Enoxaparin
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Overall Study
inappropriate Xa level timing
|
6
|
3
|
|
Overall Study
no peak Xa level drawn
|
2
|
0
|
|
Overall Study
bled prior to Xa level
|
1
|
2
|
Baseline Characteristics
Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
Baseline characteristics by cohort
| Measure |
Fixed Dose Enoxaparin
n=65 Participants
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=66 Participants
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Total
n=131 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
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 hoursNumber of patients with in range initial peak Xa level
Outcome measures
| Measure |
Fixed Dose Enoxaparin
n=56 Participants
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=61 Participants
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Number of Patients With in Range Initial Peak Xa Level
|
27 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 90 daysAny symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Outcome measures
| Measure |
Fixed Dose Enoxaparin
n=65 Participants
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=66 Participants
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Number of Participants With Venous Thromboembolism Events or Death
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysBleeding events requiring alteration in the course of care within 90 days of surgery
Outcome measures
| Measure |
Fixed Dose Enoxaparin
n=65 Participants
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=66 Participants
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Number of Participants With Bleeding Events
|
1 Participants
|
3 Participants
|
Adverse Events
Fixed Dose Enoxaparin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Weight Tiered Enoxaparin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fixed Dose Enoxaparin
n=65 participants at risk
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=66 participants at risk
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
90-day Death
|
1.5%
1/65 • Number of events 1 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
0.00%
0/66 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
Other adverse events
| Measure |
Fixed Dose Enoxaparin
n=65 participants at risk
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
Fixed Dose Enoxaparin: Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
Weight Tiered Enoxaparin
n=66 participants at risk
Eligible patients will be receive weight tiered daily enoxaparin. Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg.
Variable Dose Enoxaparin: Patients \<70kg received 30mg, patients 70kg to 89.9kg received 40mg, and patients ≥90kg received 50mg. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
DVT/PE
|
0.00%
0/65 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
0.00%
0/66 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
|
Blood and lymphatic system disorders
clinically relevant bleeding
|
1.5%
1/65 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
4.5%
3/66 • 90 days
Symptomatic VTE was defined as any symptomatic deep vein thrombosis or pulmonary embolus with imaging confirmation. Screening duplex ultrasound was not performed, as suggested by current American College of Chest Physicians guidelines. Clinically relevant bleeding was defined as any bleeding that changed the course of care; this included bleeding requiring enoxaparin cessation, unexpected transfusion, or procedural (interventional radiology or operating room) intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place