HemorrhageNCT02690090
Safety Study of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency
An observational study of Hemorrhage, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult critically ill patients with creatinine clearance < 30 mL/min and requiring thromboprophylaxis during their ICU course.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Marc Carrier, M.D. contact
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Rakesh V Patel, MD, 613.737.9830, rpatel@ohri.ca
Lana A Castellucci, MD, 613.737.9830, lcastellucci@ohri.ca
About this study
Official title: Phase 4 Study Determining the Safety of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency
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.
Read the detailed description
Objectives:
To determine the feasibility of conducting a single centre, open-label, prospective study to inform preparation for a prospective phase III study evaluating the efficacy \& safety of enoxaparin prophylaxis in critically ill adults with creatinine clearance < 30 mL/min.
Study Design:
A pilot open-label, single-arm, prospective study.
Patients:
Critically ill adults (> 18 years) with creatinine clearance < 30 mL/min.
Setting:
The Ottawa Hospital Intensive Care Units
Sample Size: n=30.
Intervention:
Study patients will receive enoxaparin 30 mg S.C. daily for VTE prophylaxis as directed by their responsible Intensivist. The investigators are not directing this clinical intervention in any manner.
Primary/Feasibility Outcomes: screening and enrolment rates with a goal of recruiting at least 5 patients collectively, from both ICUs, per month.
Secondary/Clinical Outcomes: Determining the accumulation of anti-Xa concentrations, if any, recording of the rates of major bleeding, VTE, and HIT during the study.
Trial Duration:
Anticipated 24 months.
Analysis:
Statistical analysis will be performed using SAS software through the Ottawa Hospital Methods Centre. Patient demographics and clinical baseline characteristics will be described. Continuous variables will be presented as mean (SD), ordinal variables as medians (IQR) and categorical variables as proportions. Cox proportional hazards analysis will be used to evaluate an association between trough anti-Xa levels and major bleeding.
- Conditions
- Hemorrhage
- Keywords
- Deep Vein Thrombosis, Prophylaxis, Critically ill adults
- Medical subject headings
- Hemorrhage, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| enoxaparin | enoxaparin prophylaxis as directed by treating Intensivist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
This is a pilot feasibility study
Measured: 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
Trough Anti-Xa concentration at baseline, 4, 8, 12, 16 \& 24 hours of ICU day 1
Measured: 24 hours
Record incidence of major bleeding episodes using the HEME bleeding assessment tool
Measured: Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less
Record incidence of VTE
Measured: 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
Trough Anti-Xa concentration will be measured on days; 2, 3, 4, 7 \& day of ICU discharge or ICU day 10, whichever is less
Measured: ICU stay until discharge or a maximum of the first 10 days of ICU stay, whichever is less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2014
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Rakesh V Patel, MD PharmD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690090
- Sponsor's protocol ID
- Enox-TOH-0001-RP
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Determining the Safety of Enoxaparin Prophylaxis in Critically Ill Adults With Severe Renal Insufficiency
- ClinicalTrials.gov ID
- NCT02690090
- Acronym / sponsor ID
- Enox-TOH-0001-RP
- Conditions
- Hemorrhage
- Keywords
- Deep Vein Thrombosis, Prophylaxis, Critically ill adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
To determine the feasibility of conducting a single centre, open-label, prospective study to inform preparation for a prospective phase III study evaluating the efficacy \& safety of enoxaparin prophylaxis in critically ill adults with creatinine clearance < 30 mL/min.
Study Design:
A pilot open-label, single-arm, prospective study.
Patients:
Critically ill adults (> 18 years) with creatinine clearance < 30 mL/min.
Setting:
The Ottawa Hospital Intensive Care Units
Sample Size: n=30.
Intervention:
Study patients will receive enoxaparin 30 mg S.C. daily for VTE prophylaxis as directed by their responsible Intensivist. The investigators are not directing this clinical intervention in any manner.
Primary/Feasibility Outcomes: screening and enrolment rates with a goal of recruiting at least 5 patients collectively, from both ICUs, per month.
Secondary/Clinical Outcomes: Determining the accumulation of anti-Xa concentrations, if any, recording of the rates of major bleeding, VTE, and HIT during the study.
Trial Duration:
Anticipated 24 months.
Analysis:
Statistical analysis will be performed using SAS software through the Ottawa Hospital Methods Centre. Patient demographics and clinical baseline characteristics will be described. Continuous variables will be presented as mean (SD), ordinal variables as medians (IQR) and categorical variables as proportions. Cox proportional hazards analysis will be used to evaluate an association between trough anti-Xa levels and major bleeding.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enoxaparin | – | –enoxaparin prophylaxis as directed by treating Intensivist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult critically ill patients with creatinine clearance < 30 mL/min and requiring thromboprophylaxis during their ICU course.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the rate of patient enrollment into this study within the 24 month allotted time frame of recruitment
Time frame: 24 months
This is a pilot feasibility study
4 secondary outcomes
Measure bioaccumulation of Enoxaparin, if any, defined as at least one trough anti-Xa level measuring > 0.4 IU/mL
Time frame: 24 hours
Record incidence of major bleeding episodes using the HEME bleeding assessment tool
Time frame: Daily until ICU discharge or a maximum of the first 10 days of ICU stay, whichever is less
Record incidence of VTE
Time frame: 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
Time frame: ICU stay until discharge or a maximum of the first 10 days of ICU stay, whichever is less
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Carrier, M.D. contact
Rakesh V Patel, MD PharmD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rakesh V Patel, M.D. (613.737.8899 ext. 78701, rpatel@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.