NCT05334654|CompletedDMC
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Sponsor study identifier
interventional
58
1 country
1
Study Start
April 20, 2022
Actual (reported)Primary Completion
June 30, 2022
Actual (reported)Study Completion
July 30, 2022
Actual (reported)Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin. Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2022
Actual (reported)April 19, 2022
Actual (reported)April 20, 2022
Actual (reported)June 30, 2022
Actual (reported)July 30, 2022
Actual (reported)Time spent under invasive mechanical ventilation
number of days that patient would require invasive mechanical ventilation
from randomization till 28 days after randomization
Incidence of vein thrombosis and embolism
from randomization till 28 days after randomization or ICU discharge
Gas Exchange
Every day till 28 days after randomization or ICU discharge
Intensive Care Unit length of stay
Up to 1 year
Intensive Care Unit mortality
Up to 1 year
Enoxaparin sodium twice daily, according to the renal function and clinical indication
Bivalirudin will be administered by continuous infusion, until day 7. Bivalirudin will be administered at dosage of 0,25 mg/kg in first 30 minutes, followed by continuous infusion of 0,2 mg/kg/h until 7 days. The infusion rate will be adjusted targeting a prothrombin time ratio of about 1.5.
Enoxaparin will be subcutaneously administered at a dosage from 4000 to 8000 twice daily according
Bivalirudin will be intravenously administered to obtain an activated prothrombin time (aPTT) of 1.5 fold of the normal values.
AOU Mater Domini
Catanzaro, Italy
Federico Longhini, MD
Magna Graecia University
58 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2022
First Posted
April 19, 2022
Study Start
April 20, 2022
Lung Aeration After Flexible Bronchoscopy in Intubated Critically Ill Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2022
Actual (reported)Study Completion
July 30, 2022
Actual (reported)Last Updated
August 19, 2022
Record last verified: 2022-08
The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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