NCT02690090

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

January 10, 2014

Last Update Submit

February 18, 2016

Conditions

Hemorrhage

Keywords

Deep Vein ThrombosisProphylaxisCritically ill adults

Outcome Measures

Primary Outcomes (1)

  • Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment

    This is a pilot feasibility study

    24 months

Secondary Outcomes (4)

  • Measure bioaccumulation of Enoxaparin, if any, defined as at least one trough anti-Xa level measuring > 0.4 IU/mL

    24 hours

  • Record incidence of major bleeding episodes using the HEME bleeding assessment tool

    Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less

  • Record incidence of VTE

    Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less

  • Measure bioaccumulation of Enoxaparin, if any, defined as at least one trough anti-Xa level measuring > 0.4 IU/mL

    ICU stay until discharge or a maximum of the first 10 days of ICU stay, whichever is less

Study Arms (1)

enoxaparin

enoxaparin prophylaxis as directed by treating Intensivist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult critically ill patients with creatinine clearance \< 30 mL/min and requiring thromboprophylaxis during their ICU course.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

MeSH Terms

Conditions

HemorrhageVenous Thrombosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Rakesh V Patel, MD PharmD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh V Patel, M.D.

CONTACT

613.737.8899rpatel@toh.on.ca

Marc Carrier, M.D.

CONTACT

mcarrier@toh.on.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

February 24, 2016

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

February 24, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)