BloodlossNCT00801190
This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery
A study testing HES (130/0.4) and Ringer's Lactate in people with Bloodloss, run by St. Boniface Hospital.
Trial summary
The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bloodloss
- What is being tested?
- HES (130/0.4) and Ringer's Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Apr 2011
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 - 85 years of age, inclusive
- Willing and able to provide informed consent
- Elective primary coronary artery bypass graft (CABG) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus CABG.
Who cannot join
- Emergency surgery (< 12 hours from determination of need for surgery)
- Significant other concomitant surgery (including, but not limited to, multiple valve replacement, CEA, planned circulatory arrest, etc.)
- LVEF < 25 %
- Preoperative use of inotropes
- Preoperative intraoartic balloon pump (IABP)
- Renal dysfunction: Serum Creatinine >140 μmol/L
Show all 16Show fewer
- Hepatic dysfunction: AST or ALT > 2.5 x upper limit normal; or otherwise known hepatic disease
- Preoperative Hb < 100 g/L
- Platelet count <100,000/mm3,
- INR > 1.3; PTT > 38 sec (with the exception of patients receiving preoperative heparin)
- History or family history of bleeding disorder
- Patients currently receiving: Eptifibatide (Integrilin) within 12 hours Danaparoid, Enoxaparin sodium (Lovenox) or other low molecular weight heparin within 24 hours ,Clopidogrel (Plavix) within 7 days ,Warfarin (Coumadin) within 5 days, Ticlopidine (Ticlid) within 7 day
- Dermatological syndromes with pruritus
- Planned neuraxial anesthetic technique
- Receipt of an investigational drug or device, within 30 days prior to study treatment
- Pregnant or breast feeding females
About this study
Official title: A Prospective Randomized Double-Blind Placebo-Controlled Trial of the Effects of Colloid (HES 130/0.4) Versus Crystalloid (Ringer's Lactate) on Bleeding in Patients Undergoing Cardiopulmonary Bypass for Primary CABG, Single Valve Repair/Replacement, or Combined Single Valve/CABG Surgery"
The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
- Conditions
- Bloodloss
- Being tested
- HES (130/0.4), Ringer's Lactate
- Keywords
- colloid, CABG, cardiopulmonary bypass, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES (130/0.4)Other
Also called Voluven
33 ml/kg i.v. during surgery
Ringer's LactateOther
33 ml/kg i.v.
| Study group | Role | What they receive |
|---|---|---|
| HES (130/0.4) | Active comparator | 33 ml/kg i.v. HES (130/0.4) Receives: Other: HES (130/0.4) |
| Ringer's Lactate | Placebo comparator | 33 ml/kg i.v. Rigner's Lactate Receives: Other: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB).
Measured: first 24 postoperative hours
Secondary outcomes (3)
Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
Measured: first 24 postoperative hours
Re-exploration for bleeding
Measured: first 24 postoperative hours
Total intravenous volume administration required in OR and during first 24 hours post-op hours.
Measured: first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodlossStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801190
- Sponsor's protocol ID
- HES
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Placebo-Controlled Trial of the Effects of Colloid (HES 130/0.4) Versus Crystalloid (Ringer's Lactate) on Bleeding in Patients Undergoing Cardiopulmonary Bypass for Primary CABG, Single Valve Repair/Replacement, or Combined Single Valve/CABG Surgery"
- ClinicalTrials.gov ID
- NCT00801190
- Acronym / sponsor ID
- HES
- Conditions
- Bloodloss
- Keywords
- colloid, CABG, cardiopulmonary bypass, bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 3 Dec 2008 (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 overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES (130/0.4) | Active comparator | Other: HES (130/0.4)33 ml/kg i.v. HES (130/0.4) |
| Ringer's Lactate | Placebo comparator | Other: Ringer's Lactate33 ml/kg i.v. Rigner's Lactate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 - 85 years of age, inclusive
- Willing and able to provide informed consent
- Elective primary coronary artery bypass graft (CABG) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus CABG.
Key exclusion criteria (16 listed)
- Emergency surgery (< 12 hours from determination of need for surgery)
- Significant other concomitant surgery (including, but not limited to, multiple valve replacement, CEA, planned circulatory arrest, etc.)
- LVEF < 25 %
- Preoperative use of inotropes
- Preoperative intraoartic balloon pump (IABP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HES (130/0.4)Also: Voluven33 ml/kg i.v. during surgery | Other | HES (130/0.4) |
| Ringer's Lactate33 ml/kg i.v. | Other | Ringer's Lactate |
Primary outcome
To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB).
Time frame: first 24 postoperative hours
3 secondary outcomes
Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
Time frame: first 24 postoperative hours
Re-exploration for bleeding
Time frame: first 24 postoperative hours
Total intravenous volume administration required in OR and during first 24 hours post-op hours.
Time frame: first 24 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HES (130/0.4) and Ringer's Lactate in people with Bloodloss, run by St. Boniface Hospital.
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 3 inclusion and 16 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 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB). (time frame: first 24 postoperative hours). 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 3 Dec 2008.