- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188747
Comparison of Three Management Strategies for Post Cardiac Surgery Bleeding
October 10, 2006 updated by: University Health Network, Toronto
Comparison of Three Management Strategies for Post Cardiac Surgery Coagulopathy.
Open-heart surgery frequently results in abnormal clotting, which in turn results in excessive blood loss and the need for transfusion of multiple blood products to patients and leads to adverse outcomes.
Prompt identification of any clotting abnormalities after cardiac surgery reduces blood loss and blood product transfusion and may improve outcomes.
Currently, however, this monitoring is dependent on standard laboratory-based tests of clotting that have a long turnaround time (30-45 min) and do not measure some important aspect of clotting.
There are now other monitoring options that are carried out at patients' bedside, providing results more quickly than standard laboratory tests (within 2-5 minutes for some), and measure more aspects of clotting, providing more information on possible causes of any abnormalities.
In this study, we will compare the cost-effectiveness of two of these newer monitoring techniques with standard laboratory-based tests by assigning 150 patients who will be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will be assigned by chance to each group).
In each group, an explicit algorithm based on the monitoring technique of that group will be used to guide all transfusion decisions.
Between-group differences in number of units of blood products transfused (primary outcome), amount of blood loss, rate of adverse events, and cost of monitoring will be measured.
The objective of the study is to determine which of the three methods is most cost-effective in terms of these outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital, University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- greater than 18 years
- no emergent complex cardiac surgery
Exclusion Criteria:
- Isolated CABG
- Single valve surgery
- Pre-existing coagulopathy PTT>50's, INR>1.3
- Severe Thrombocytopenia Platelet <100,000
- Recent Antiplatelet drugs(Plavix within 7 days, Integrilin within 24 hours)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Units of blood products transfused in the first 24 hours post CPB.
|
Secondary Outcome Measures
Outcome Measure |
---|
Test cost, chest tube blood loss 24h; blood products in the postoperative period; modifications in transfusion that would have occurred if result from other group's tests were available; length of stay ICU and hospital; incidence of major complications.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Keyvan Karkouti, MD, Toronto General Hospital, University Health Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
October 11, 2006
Last Update Submitted That Met QC Criteria
October 10, 2006
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 05-0054-B
- Anemia Institute #04-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Disease
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
University of PennsylvaniaCompleted
-
Abbott Medical DevicesRecruitingAortic Valve Disease | Valvular Heart DiseaseChina
-
Mansoura UniversitySuspendedValve Heart Disease | Elective Cesarean DeliveryEgypt
-
Tulane UniversityCompletedCardiomyopathies | Valvular Heart Disease | Pericardial DiseaseUnited States
-
Assiut UniversityCompleted
-
InnovHeartActive, not recruitingHeart Valve Diseases | Mitral Regurgitation | Valve Heart Disease | Mitral Valve Disease | Mitral DiseaseLithuania, Denmark, Hungary
-
Aarhus University Hospital SkejbyInstitute for Clinical and Experimental MedicineCompletedHeart Failure | Coronary Heart Disease | Ischemic Heart DiseasesDenmark
-
Fundació Institut de Recerca de l'Hospital de la...UnknownValvular Heart Disease | Cardiac Disease | Nurse's Role | CompetenceSpain
Clinical Trials on Thromboelastograph, Point of Care
-
Goethe UniversityUniversity Hospital, EssenCompletedCardiac Surgery | Coagulation ManagementGermany
-
Temple UniversityCompleted
-
Medical University of ViennaWithdrawnTelemedicine | EchocardiographyAustria
-
University College, LondonRecruiting
-
International Centre for Diarrhoeal Disease Research...RecruitingLactate Blood Increase | Severe Sepsis With Septic ShockBangladesh
-
WellSpan HealthStony Brook University; University of California, IrvineRecruitingPulmonary EmbolismUnited States
-
Second Affiliated Hospital, School of Medicine,...CompletedCOVID-19 | Weaning | Lung Ultrasound | Diaphragm UltrasoundChina
-
Cliniques universitaires Saint-Luc- Université...Completed