Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) (IMPACT)
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| ClinicalTrials.gov Identifier: NCT04406389 |
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Recruitment Status :
Recruiting
First Posted : May 28, 2020
Last Update Posted : January 26, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Enoxaparin sodium Drug: Unfractionated heparin Drug: Fondapariniux Drug: Argatroban | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 186 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial) |
| Actual Study Start Date : | October 13, 2020 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intermediate Dose Prophylaxis
Subjects will receive one of the following interventions, at their physician's discretion:
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Drug: 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 Other Name: Lovenox Drug: 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 Other Name: Sodium heparin Drug: Fondapariniux Intermediate Dose Prophylaxis Arm: 2.5 mg daily subcutaneously Therapeutic Dose Anticoagulation Arm: Dose by weight:
Other Name: Arixtra |
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Experimental: Therapeutic Dose Anticoagulation
Subjects will receive one of the following interventions, at their physician's discretion:
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Drug: 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 Other Name: Lovenox Drug: 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 Other Name: Sodium heparin Drug: Fondapariniux Intermediate Dose Prophylaxis Arm: 2.5 mg daily subcutaneously Therapeutic Dose Anticoagulation Arm: Dose by weight:
Other Name: Arixtra Drug: Argatroban Therapeutic Dose Anticoagulation Arm: Dosed according to institutional protocol |
- 30-day mortality [ Time Frame: 30 days ]Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
- Length of Intensive Care Unit (ICU) Stay in Days [ Time Frame: 6 months ]Comparison of length of ICU stay in days between each treatment arm.
- Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events [ Time Frame: 6 months ]Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
- Number of major and clinically relevant non-major bleeding events [ Time Frame: 6 months ]Comparison 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years old
- COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection with detectable SARS-CoV-2 IgG or IgM.
- Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
- D dimer level greater than 700 ng/mL (3 times the upper limit of normal).
Exclusion Criteria:
- Objectively documented deep vein thrombosis or pulmonary embolism
- Patients in whom there is very high suspicion for pulmonary embolism and are on full-dose anticoagulation as per the treating physician
- Platelets <30,000 not due to disseminated intravascular coagulation (DIC), based on the International Society of Thrombosis and Haemostasis (ISTH) criteria and American Society of Hematology (ASH) Frequently Asked Questions
- Active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator.
- History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe thrombocytopathy)
- History of intracranial hemorrhage in the last 90 days
- History of ischemic stroke in the past 2 weeks
- Major neurosurgical procedure in the past 30 days
- Cardiothoracic surgery in the past 30 days
- Intra-abdominal surgery in the past 30 days
- Intracranial malignancy
- Patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid syndrome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406389
| Contact: Maria T DeSancho, MD, MSc | 646-962-2065 | mtd2002@med.cornell.edu | |
| Contact: Marina Loizou | 212-746-2190 | mal2091@med.cornell.edu |
| United States, New York | |
| Weill Cornell Medicine | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Maria T DeSancho, MD, MSc 646-962-2065 mtd2002@med.cornell.edu | |
| Contact: Marina Loizou 212-746-2190 mal2091@med.cornell.edu | |
| Principal Investigator: Maria T DeSancho, MD, MSc | |
| Principal Investigator: | Maria T DeSancho, MD, MSc | Weill Medical College of Cornell University |
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT04406389 |
| Other Study ID Numbers: |
20-04021936 |
| First Posted: | May 28, 2020 Key Record Dates |
| Last Update Posted: | January 26, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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COVID-19 Anticoagulation |
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Critical Illness Disease Attributes Pathologic Processes Heparin Calcium heparin Enoxaparin Argatroban Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors |