Table 1 World Health Organization trial registration data set
Data category | Information |
|---|---|
Primary registry and trial identifying number | EU clinical trials register: |
EudraCT number: 2012-004368-23 | |
Date of registration in primary registry | 25/09/2012 |
Secondary identifying numbers | Danish health and medicines authority: 2012100176 |
Danish national scientific ethical committee: 1210528 Sponsor's protocol number 20121005 | |
Source(s) of monetary or material support | Danish society of anesthesiology & intensive medicine’s research initiative |
Odense University Hospital’s research grant | |
Lippmann fund | |
Primary sponsor | Palle Toft, Professor at the department of Anesthesiology and Intensive Care at Odense University Hospital, Odense, Denmark. |
Secondary sponsor(s) | N/A |
Contact for public queries | Sian Robinson, MB, BS; EDIC |
Odense University Hospital | |
Department of Anesthesiology and Intensive Care | |
Sdr. Boulevard 29. Odense C | |
DK 5000. Denmark | |
Telephone: +45 6541 5519 | |
Email: sian.robinson@rsyd.dk | |
Contact for scientific queries | Sian Robinson, MB, BS; EDIC |
Principal investigator | |
Odense University Hospital | |
Department of Anesthesiology and Intensive Care | |
Sdr. Boulevard 29. Odense C | |
DK 5000. Denmark | |
Telephone: +45 6541 5519 | |
Email: sian.robinson@rsyd.dk | |
Public title | A feasible strategy for preventing blood clots in critically ill patients with acute kidney injury (FBI) |
Scientific title | A feasible strategy for preventing blood clots in critically ill patients with acute kidney injury (FBI) - prospective randomized, double-blind multicenter study |
Countries of recruitment | Denmark |
Health condition(s) or problem(s) studied | Venous thromboembolism, enoxaparin dose, acute kidney injury, bleeding |
Intervention(s) | Treatment arm: 1 mg/kg enoxaparin subcutaneous once daily |
Control arm: 40 mg enoxaparin subcutaneous once daily | |
Enoxaparin will be administered subcutaneously to the thigh or abdomen of the study patients from the day of inclusion, until the end of each participant’s study period. | |
Key inclusion and exclusion criteria | Inclusion criteria: patients are eligible if they give consent, develop acute kidney injury, need continuous renal replacement therapy, weigh 45 to 150 kg, and are ≥18 years. |
Exclusion criteria: these include a) admission diagnosis of major trauma, b) need for therapeutic anticoagulation, c) contraindication to heparin (allergy or heparin-induced thrombocytopenia), d) pregnancy, e) life-support limitation, f) uncontrolled hypertension (bp > 180/110) for at least 12 hours, g) cerebral hemorrhage/acute gastrointestinal bleed, h) severe thrombocytopenia (platelet count <50 × 109/l), i) International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) ≥2 times the upper limit of normal, j) chronic renal failure or acute-on-chronic renal failure, and k) initial evaluation more than 24 hours after commencement of continuous renal replacement therapy. | |
Study type | Interventional allocation: randomized |
Intervention model: double arm | |
Masking: double blind (subject, relatives, investigator, outcomes assessor) | |
Primary purpose: prevention | |
Date of first enrolment | March 2013 |
Target sample size | 266 |
Recruitment status | Recruiting |
Primary outcome(s) | Venous thromboembolism |
Key secondary outcomes | Catheter-related thrombus, anti-Xa activity, bleeding, heparin-induced thrombocytopenia, filter lifespan, length of stay, ventilator free days, and mortality. We will monitor neutrophil gelatinase-associated lipocalin levels and urine volume to determine whether they can be used as prognostic factors for renal recovery. |