NCT00246779

Brief Summary

Cardiac surgery is a major consumer of blood products worldwide. The nature of the surgery when the heart-lung machine is used, is such that the patient's blood is significantly diluted by intravenous fluids. This dilution further compounds the blood's ability to form blood clots to seal the wound, thus increasing bleeding after surgery. The problem of this dilution is particularly severe in patients with low body weight, of whom a large percentage are women undergoing heart surgery. As a result, in this population there is an increased risk of needing a blood transfusion during and after surgery. The effects of this dilution can be potentially reversed by filtering the blood and removing the fluid after the principal part of the procedure has been completed through a process referred to as modified ultrafiltration (MUF). This procedure has been shown to be effective in several small clinical studies, however the interpretation of the results has been complicated by the fact that the studies were not "blinded". In other words, because the physicians and surgeons making the decisions about blood transfusions knew what treatment the patients received (i.e. MUF or not) it may have biased their judgement and affected the validity of the findings of the studies. The investigators believe that MUF may be a useful procedure to limit blood transfusions, particularly in patients of low body size, and weight undergoing heart surgery. This can only be demonstrated in a large clinical trial, and in the best case scenario, in a trial in which total blinding has been undertaken. However, blinding in this manner is quite difficult to achieve and it is necessary first to demonstrate that this is possible. Further, as the trial will involve several heart centers, it is essential to demonstrate that the relatively complex study interventions can be carried out in each of the centers in a reproducible manner. With this data in hand, the investigators will be able to submit for funding at a later date for a very large trial to determine if MUF decreases the need for blood transfusions in heart surgery patients. The investigators will also be able to determine the effect of this in terms of helping conserve blood as a benefit to the blood-banking agency (the Canadian Blood Service).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

4 active sites

Status
completed

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

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

First QC Date

October 27, 2005

Last Update Submit

September 25, 2019

Conditions

Heart Diseases

Keywords

transfusioncardiac surgerymodified ultrafiltrationCardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Success of intraoperative blinding as determined by Blinding Index

Secondary Outcomes (6)

  • Compliance

  • Screening and recruitment rates

  • Confirmation of safety

  • Establishing feasibility of multi-center approach

  • Collection of data for power calculation of final trial

  • +1 more secondary outcomes

Interventions

Modified ultrafiltrationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult cardiac surgery patients with weight ≤ 65 kg or body surface area (BSA) \< 1.7 m2

You may not qualify if:

  • Emergency surgery
  • Abciximab (Reopro™) use \< 7 days
  • Inability to obtain consent
  • Age \< 18 years
  • Patients undergoing off-pump surgery
  • Preoperative anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

University Hospital

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

  • Boodhwani M, Hamilton A, de Varennes B, Mesana T, Williams K, Wells GA, Nathan H, Dupuis JY, Babaev A, Wells P, Rubens FD. A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):701-6. doi: 10.1016/j.jtcvs.2009.11.056.

    PMID: 20176212RESULT

Related Links

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Fraser D Rubens, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

  • Howard J. Nathan, MD

    University of Ottawa

    STUDY CHAIR

  • Thierry Mesana, MD

    University of Ottawa

    STUDY CHAIR

  • Phil Wells, MD

    University of Ottawa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

November 1, 2005

Study Completion

June 1, 2007

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CA(4)