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Trial - NCT04373707


Column Value
Trial registration number NCT04373707
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04373707

First author
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

Stéphane Zuily, MD, PhD

Contact
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

Yohann Bernard, y.bernard@chru-nancy.Fr (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-04

Recruitment status
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - adult patient hospitalized for a probable/confirmed covid-19 infection (confirmed by serology/polymerase chain reaction or by radiologic signs of covid-19 pneumonia in the setting of clinical and laboratory abnormalities suggestive of a sars-cov-2 infection) - signed informed consent - patient affiliated to the social security

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- renal insufficiency with a gfr<15 ml/min/1.73m² - acute kidney injury kdigo3 - prophylactic dose of low molecular weight heparin for more than 3 days - curative dose of low molecular weight heparin for more than 1 day - recurrent catheter/hemodialysis access thromboses - ecmo required in the next 24h - contraindication to low molecular weight heparin - high bleeding risk (e.g. uncontrolled severe systemic hypertension, recent major bleeding, disseminated intravascular coagulopathy, thrombocytopenia < 75g/l) - history of heparin-induced thrombocytopenia - contraindication to blood-derived products - impossibility to perform a doppler ultrasound of the lower limbs (e.g. above the knee amputation, severe burn injuries) - expected death in the next 48h - vulnerable subjects according to articles l. 1121-5, l. 1121-7 et l1121-8 of french public health code

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Central Hospital, Nancy, France

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 22, 2021, 3 a.m.
Source : ClinicalTrials.gov

1000

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Venous thromboembolism

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "It can be either Enoxaparin, Tinzaparin, Nadroparin, Dalteparin. The dose changes between the 2 groups ", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "It can be either Enoxaparin, Tinzaparin, Nadroparin, Dalteparin. The dose changes between the 2 groups ", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]