Trial · NCT04401293
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
NCT04401293, Phase 3, Completed, Northwell Health; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients. Trials, record NCT04401293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04401293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients
- NCT number
- NCT04401293
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 257 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Sars-CoV2, COVID
- Interventions
- Enoxaparin, Prophylactic/Intermediate Dose Enoxaparin
- First posted
- 2020-05-26
- Last updated
- 2021-11-22
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. | Day 30 ± 2 days | Risk of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Day 30 ± 2 days. |
| Secondary | Major Bleeding | Day 30 ± 2 days | Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria |
| Secondary | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 | Day 10 + 4 | The composite of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Hospital Day 10 + 4 |
| Secondary | Sepsis-induced Coagulopathy (SIC) Score | Day 30 ± 2 days. | Sepsis-induced coagulopathy (SIC) score predicts likelihood of sepsis-induced coagulopathy based on ISTH guidelines. The score uses the following domains: * Platelets, K/uL (thousands per microliter) * INR (International Normalized Ratio) * D-Dimer Level * Fibrinogen Platelet count \> 100 cells x 10\^9/L is 0 points, platelet count 50 to 100 cells x 10\^9/L is 1 point and Platelet count \< 50 cells x 10\^9/L is 2 points. INR \< 1.3 is 0 points, INR 1.3 to 1.7 is 1 point and INR \> 1.7 is 2 points. D-Dimer level \< 400 ng/mL is 0 points, D-Dimer level 400-4000 ng/mL is 2 points and D-Dimer level \> 4000 ng/mL is 3 points. Fibrinogen level \> 100 mg/dL is 0 points and fibrinogen level \< 100 mg/dL is 1 point. Calculated (SIC) scores yields a possible 0 to 6 points, where ≥4 predicts higher mortality rates within 30 days and greater risk of pulmonary embolism. |
| Secondary | Progression to Acute Respiratory Distress Syndrome (ARDS) | Day 30 ± 2 days. | Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions. |
| Secondary | Need for Intubation | Day 30 ± 2 days. | Need for Intubation will be based on monitoring of patient conditions. |
| Secondary | Re-hospitalization | Day 30 ± 2 days. | Need for Re-hospitalization will be based on monitoring of patient conditions. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. | Day 30 ± 2 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Major Bleeding | Day 30 ± 2 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 | Day 10 + 4 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sepsis-induced Coagulopathy (SIC) Score | Day 30 ± 2 days. | COVID-19 patients have been noted to have significantly elevated markers of hypercoagulability including d-dimer (Dd), fibrinogen levels, FVIII levels, short activated partial thromboplastin time (aPTT) and Sepsis-Induced Coagulopathy (SIC) scores with an increase in venous thromboembolic disease as well as cardiac injury. | units on a scale | MEAN |
| SECONDARY | Progression to Acute Respiratory Distress Syndrome (ARDS) | Day 30 ± 2 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Need for Intubation | Day 30 ± 2 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Re-hospitalization | Day 30 ± 2 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. | Full Dose LMWH Anticoagulation Therapy | 25 | Participants | ||
| Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 31 | Participants | ||
| Major Bleeding | Full Dose LMWH Anticoagulation Therapy | 6 | Participants | ||
| Major Bleeding | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 2 | Participants | ||
| Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 | Full Dose LMWH Anticoagulation Therapy | 2 | Participants | ||
| Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 3 | Participants | ||
| Sepsis-induced Coagulopathy (SIC) Score | Full Dose LMWH Anticoagulation Therapy | 2.35 | Standard Deviation 0.73 | units on a scale | |
| Sepsis-induced Coagulopathy (SIC) Score | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 2.31 | Standard Deviation 0.85 | units on a scale | |
| Progression to Acute Respiratory Distress Syndrome (ARDS) | Full Dose LMWH Anticoagulation Therapy | 11 | Participants | ||
| Progression to Acute Respiratory Distress Syndrome (ARDS) | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 6 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Full Dose LMWH Anticoagulation Therapy | 130 | |
| Overall Study | STARTED | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 127 | |
| Overall Study | COMPLETED | Full Dose LMWH Anticoagulation Therapy | 129 | |
| Overall Study | COMPLETED | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 124 | |
| Overall Study | NOT COMPLETED | Full Dose LMWH Anticoagulation Therapy | 1 | |
| Overall Study | NOT COMPLETED | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 3 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Full Dose LMWH Anticoagulation Therapy | 2 | 129 | 2 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 0 | 124 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Full Dose LMWH Anticoagulation Therapy | 25 | 129 |
| Total, all-cause mortality | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 31 | 124 |
| Total, other adverse events | Full Dose LMWH Anticoagulation Therapy | 0 | 129 |
| Total, other adverse events | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 0 | 124 |
| Total, serious adverse events | Full Dose LMWH Anticoagulation Therapy | 2 | 129 |
| Total, serious adverse events | Prophylactic/Intermediate Dose LMWH or UFH Therapy | 0 | 124 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Re-hospitalization | Trial comparisons |
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Major Bleeding | Trial comparisons |
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Progression to Acute Respiratory Distress Syndrome (ARDS) | Trial comparisons |
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Need for Intubation | Trial comparisons |
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: deaths from any cause | Trial comparisons |
Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 | Trial comparisons |
Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. | Trial comparisons |
| Full Dose LMWH Anticoagulation Therapy vs Prophylactic/Intermediate Dose LMWH or UFH Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04401293
GET https://conductscience.org/api/trials/v1/NCT04401293/registered