Lins 2020.

Study name	CoV‐Hep Study: randomized and paired clinical trial comparing regional anticoagulation modalities in continuous venous venous hemodialysis in patients with COVID‐19
Starting date	29 June 2020
Contact information	Paulo Lins, MD University of São Paulo General Hospital São Paulo, SP, Brazil, 05403‐010 +55.11.98279‐2696 | paulo.lins@hc.fm.usp.br
Methods	Open‐label, 2‐armed, parallel RCT
Participants	90 participants, ≥ 18 years, female and male Inclusion criteria: Confirmed or probable SARS‐CoV‐2 infection Presence of acute kidney injury with indication and agreement between ICU and nephrology teams for the introduction of renal CVVHD Exclusion criteria: Hypersensitivity to any of the substances used in the study (citric acid dextrosol 2.2% and UFH) Previous diagnosis of coagulopathy or thrombophilia Contraindication to the use of UFH by the assistant team Risk of citrate poisoning ‐ (lactate > 30 mg/dL, INR > 2.5, total bilirubin > 15mg/dL) Pregnancy
Interventions	Experimental: Participants on continuous haemodialysis (blood flow 150 mL/min, dose of 30 mL/kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L associated with UFH at 10 U/kg/h Addition of UFH to CVVHD system already running under citrate regional anticoagulation Comparator Participants on continuous haemodialysis (blood flow 150 mL/min, dose of 30 mL/kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L
Outcomes	Primary Clotted dialyzers (time frame: Day 3 of dialysis ) The percentage of clotted dialyzers within 72 h in each of the studied groups. Secondary Time‐free of clotting (time frame: day 3 of dialysis) Number of h until a dialyser clots in the first 72 h of dialysis Number of dialysers used (time frame: day 3 of dialysis) The amount of dialysers used in the first 72 h of haemodialysis Pressure variation (time frame: day 3 of dialysis) Variation in dialysis system and vascular access pressures in the first 72 h of dialysis Urea sieving (time frame: day 3 of dialysis) Variation in urea sieving between the first, second and third days of dialysis Downtime of dialysis (time frame: day 3 of dialysis) Time of dialysis stop due to clotting in the first 72 h
Notes	NCT04487990 | No data provided |