Trial NCT04360824
Publication Perepu U, J Thromb Haemost, 2021 (published paper)
Dates: 2020-04-26 to 2021-01-06
Funding: Public/non profit (National Institutes of Health Clinical and Translational Science Award)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / USA Follow-up duration (days): 30 | |
Inclusion criteria | Adults 18 years of age or older; SARS-CoV-2 infection confirmed by nasopharyngeal swab polymerase chain reaction; requiring hospitalization; admitted to an ICU and/or had a modified ISTH Overt DIC score ≥ 3 |
Exclusion criteria | Indication for full therapeutic dose anticoagulation or they had active major bleeding; severe thrombocytopenia (platelet count <25,000/uL); current pregnancy; a history of acute venous or arterial thrombosis within the prior 3 months; or acute or chronic renal insufficiency with an estimated creatinine clearance less than 30 mL/min calculated by the modified Cockcroft and Gault formula |
Interventions | |
Treatment
Intermediate-Dose Enoxaparin 1 mg/kg daily if BMI < 30; 0.5 mg/kg twice daily if BMI ≥ 30; subcutaneously. |
|
Control
Standard-Dose prophylactic anticoagulation ( / ) | |
Participants | |
Randomized 176 participants (n1=88 / n2= 88) | |
Characteristics of participants N=176 Mean age : NR 97 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=* | |
Primary outcome | |
In the register Mortality [ Time Frame: 30 Days post intervention ] | |
In the report All-cause mortality at 30 days | |
Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated NR |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
General comment | In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available at time of extraction. There were some differences between inclusion criteria in the registry and the article: the registry required a modified ISTH Overt DIC score ≥ 3 whereas in the article the criteria included admitted to an ICU and/or a modified ISTH Overt DIC score ≥ 3. Several secondary outcomes in the registry were not reported (Packed Red Blood Cell Transfusions, Platelet Transfusions, Fresh Frozen Plasma Transfusions, Cryoprecipitate Transfusions, Prothrombin Complex Concentrate Transfusions) while other reported secondary outcomes (acute kidney injury, ischemic stroke and myocardial infarction) were not in the registry. Exploratory laboratory biomarker outcomes will be reported separately. The study achieved its target sample size. On 27th of July, 2021, this study was updated based on published article, supplemental material, and protocol. |