Trial Outcomes & Findings for Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) (NCT NCT04406389)
NCT ID: NCT04406389
Last Updated: 2023-09-21
Results Overview
Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
30 days
Results posted on
2023-09-21
Participant Flow
1 subject signed consent but failed screening and was not randomized.
Participant milestones
| Measure |
Intermediate Dose Prophylaxis
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
|
Overall Study
COMPLETED
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Baseline characteristics by cohort
| Measure |
Intermediate Dose Prophylaxis
n=4 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
Total
n=14 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Subject Location at Time of Randomization
Intensive Care Unit
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Subject Location at Time of Randomization
Ward
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Respiratory Support at Time of Randomization
High Flow Nasal Cannula or Non-Invasive Ventilation (>15 L/min)
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Respiratory Support at Time of Randomization
Invasive Mechanical Ventilation or ECMO
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Respiratory Support at Time of Randomization
Supplemental Oxygen (<15L/min)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Vasopressor Support at Time of Randomization
Subjects on Vasopressor Support
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Vasopressor Support at Time of Randomization
Subjects not on Vasopressor Support
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysComparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
Outcome measures
| Measure |
Intermediate Dose Prophylaxis
n=4 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
30-day Mortality
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome measure is only assessing participants that had an ICU stay while participating in the study. Participants that never had an ICU stay are excluded from the analysis.
Comparison of length of ICU stay in days between each treatment arm.
Outcome measures
| Measure |
Intermediate Dose Prophylaxis
n=2 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=6 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Length of Intensive Care Unit (ICU) Stay in Days
|
25.5 Days
Interval 10.0 to 41.0
|
25 Days
Interval 15.0 to 111.0
|
SECONDARY outcome
Timeframe: 6 monthsComparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
Outcome measures
| Measure |
Intermediate Dose Prophylaxis
n=4 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Venous Thromboembolism Events
|
1 Count of Events
|
0 Count of Events
|
|
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Arterial Thrombosis Events
|
1 Count of Events
|
0 Count of Events
|
|
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Microthrombosis Events
|
0 Count of Events
|
1 Count of Events
|
SECONDARY outcome
Timeframe: 6 monthsComparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
Outcome measures
| Measure |
Intermediate Dose Prophylaxis
n=4 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 Participants
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Number of Major and Clinically Relevant Non-major Bleeding Events
Major Bleeding Events
|
1 Count of Events
|
1 Count of Events
|
|
Number of Major and Clinically Relevant Non-major Bleeding Events
Clinically Relevant Non-Major Bleeding Events
|
1 Count of Events
|
2 Count of Events
|
Adverse Events
Intermediate Dose Prophylaxis
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Therapeutic Dose Anticoagulation
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intermediate Dose Prophylaxis
n=4 participants at risk
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 participants at risk
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Vascular disorders
Thromboembolic Event - Pulmonary Embolism
|
25.0%
1/4 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
0.00%
0/10 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
General disorders
Multi-organ Failure
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
20.0%
2/10 • Number of events 2 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Vascular disorders
Gluteal Hematoma
|
25.0%
1/4 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
0.00%
0/10 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Nervous system disorders
Ischemic Stroke
|
25.0%
1/4 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
0.00%
0/10 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
Other adverse events
| Measure |
Intermediate Dose Prophylaxis
n=4 participants at risk
Subjects will receive one of the following interventions, at their physician's discretion:
* Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
* Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
* If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
* Fondaparinux (if history of heparin-inducted thrombocytopenia \[HIT\]) 2.5 mg daily subcutaneously
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
* If greater than or equal to 100 kg: 10 mg daily
* If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
* If less than 50 kg: 5 mg daily
|
Therapeutic Dose Anticoagulation
n=10 participants at risk
Subjects will receive one of the following interventions, at their physician's discretion:
* Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
* Enoxaparin 1 mg/kg subcutaneously every 12 hours
* Argatroban (if heparin-induced thrombocytopenia \[HIT\]), dosed according to institutional protocol.
* Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
* 100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Enoxaparin sodium: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min, OR 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
Unfractionated heparin: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
Fondapariniux: Intermediate Dose Prophylaxis Arm:
2.5mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
≥100kg: 10 mg daily \<100kg but ≥50 kg: 7.5 mg daily \<50kg: 5 mg daily
Argatroban: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
|
|---|---|---|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
20.0%
2/10 • Number of events 2 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Injury, poisoning and procedural complications
Tracheostomy Site Bleeding
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
20.0%
2/10 • Number of events 2 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
0.00%
0/10 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Renal and urinary disorders
Renal and urinary disorders, Other - Renal Failure
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Respiratory, thoracic and mediastinal disorders
Navigational Note: - Respiratory, thoracic and mediastinal disorders - Other - Oropharyngeal bleed
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/4 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
10.0%
1/10 • Number of events 1 • 6 months
Only adverse events (AEs) meeting the following criteria will be collected and reported: 1. AEs related to bleeding (any major or clinically significant non-major bleeding) or thrombotic events (DVT/PE, stroke, myocardial infarction, peripheral embolism, skin thrombosis). 2. Any AE that results in interruption or discontinuation of the assigned anticoagulant treatment. 3. Any AE that meets the criteria for serious
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place