Recruiting

Enoxaparin

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02690090

Conditions

Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The investigators study is the first step (a pilot study) in determining whether the manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are patients in an intensive care unit and have severely reduced kidney function (less than or equal to approximately 30% of their normal function) is safe with respect to the adverse effect of bleeding.

The investigators hypothesis is that studying these patients, going forward in time, without interfering with their care, to eventually determine if this blood thinner is safe at reduced doses, is feasible.

Conditions

Hemorrhage

Study ID

NCT02690090

Start date

Feb, 2014

Status verified date

Feb, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Mar, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • body weight ≥ 45 kg
  • expected ICU length of stay ≥ 72 hours
  • severe renal insufficiency, defined by calculated creatinine clearance (CrCl) < 30 mL/min using the Cockcroft-Gault formula
  • All patients with severe renal insufficiency at ICU admission will be included, regardless of chronicity of renal disease. This includes patients with pre-existing dialysis dependence via intermittent hemodialysis and peritoneal dialysis; patients with acute kidney injury requiring SLED (sustained low-efficiency dialysis) will also be included.

Exclusion Criteria:

  • neurological surgery in last 3 months
  • epidural catheter insertion within previous 12 hours
  • ICU admission > 2 weeks
  • receipt of > 2 doses of LMWH while in ICU or in hospital within 7 days prior to study enrolment
  • active bleeding; platelet count < 50 x 109/L
  • INR or aPTT > 2 times the upper limit of normal
  • need for therapeutic anticoagulation; previous adverse reaction to heparin based products
  • contraindication to blood product transfusion
  • pregnant or lactating women
  • life expectancy < 2 weeks or receiving palliative care
  • previous enrolment in current study.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

enoxaparin

enoxaparin prophylaxis as directed by treating Intensivist

Primary outcome measure

  • Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Rakesh V Patel, M.D.

613.737.8899rpatel@toh.on.ca

Marc Carrier, M.D.

mcarrier@toh.on.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Rakesh V Patel, MD

613.737.9830rpatel@ohri.ca

Lana A Castellucci, MD

613.737.9830lcastellucci@ohri.ca

Principal Investigator:

Rakesh V Patel, MD PharmD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 24, 2016

Last verified

Feb, 2016

Keywords

  • Deep Vein Thrombosis
  • Prophylaxis
  • Critically ill adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2016-02-24.