Trial Outcomes & Findings for Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19 (NCT NCT04367831)
NCT ID: NCT04367831
Last Updated: 2024-12-10
Results Overview
Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
94 participants
Primary outcome timeframe
Discharge from ICU or 30 days
Results posted on
2024-12-10
Participant Flow
Unit of analysis: Intensive Care Units
Participant milestones
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
46 4
|
48 4
|
|
Overall Study
COMPLETED
|
46 4
|
48 4
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19
Baseline characteristics by cohort
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Discharge from ICU or 30 daysComposite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU
|
28 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Discharge from hospital or 30 daysComposite of being alive and with clinically relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Total Number of Patients With Clinically Relevant Venous or Arterial Thrombotic Events in ICU
|
15 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Discharge from ICU, up to 36 daysLength of stay measured in days.
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
ICU Length of Stay
|
23 days
Interval 1.0 to 36.0
|
26 days
Interval 1.0 to 34.0
|
SECONDARY outcome
Timeframe: Discharge from ICU or 30 daysThe impact of intermediate-dose anti-coagulation compared with prophylactic anti-coagulation on rates of acute kidney injury and renal recovery in the ICU will be measured with the total number of patients who need of renal replacement therapy in the ICU.
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Total Number of Patients With the Need for Renal Replacement Therapy in the ICU
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Discharge from ICU or 30 daysMajor bleeding will be assessed by BARC criteria (\> BARC 3), also explored by International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) criteria.
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Total Number of Patients With Major Bleeding in the ICU
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Discharge from ICU, up to 36 daysLength of stay measured in days.
Outcome measures
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 Participants
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 Participants
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Hospital Length of Stay
|
17.78 days
Interval 1.0 to 36.0
|
17.73 days
Interval 1.0 to 34.0
|
Adverse Events
Intervention Arm: Intermediate-dose Anticoagulation
Serious events: 0 serious events
Other events: 15 other events
Deaths: 10 deaths
Control Arm: Prophylaxis
Serious events: 0 serious events
Other events: 12 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Arm: Intermediate-dose Anticoagulation
n=46 participants at risk
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR \<30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL
Heparin Infusion: Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Enoxaparin/Lovenox Intermediate Dose: If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
|
Control Arm: Prophylaxis
n=48 participants at risk
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR \< 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. \>120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour
Enoxaparin Prophylactic Dose: Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin SC: Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
|
|---|---|---|
|
Vascular disorders
Venous Thromboembolism
|
10.9%
5/46 • Up to 30 days
|
12.5%
6/48 • Up to 30 days
|
|
Vascular disorders
Actionable Line Thrombosis
|
13.0%
6/46 • Up to 30 days
|
14.6%
7/48 • Up to 30 days
|
|
Vascular disorders
CVVH Filter Thrombosis
|
6.5%
3/46 • Up to 30 days
|
2.1%
1/48 • Up to 30 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
32.6%
15/46 • Up to 30 days
|
25.0%
12/48 • Up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place