Heparin's Influence on ROTEM® Analysis
Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay
1 other identifier
observational
20
1 country
1
Brief Summary
Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status. The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2010
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedOctober 20, 2011
October 1, 2011
1 year
October 18, 2011
October 19, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline ROTEM® measurements after the administration of heparin
Baseline ROTEM® measurement will be compared to ROTEM® measurements after the administration of heparin, at the end of cardiopulmonary bypass and after the administration of protamine.
Study Arms (1)
coronary artery disease
patients undergoing coronary artery bypass grafting using cardiopulmonary bypass
Eligibility Criteria
Patients undergoing coronary artery bypass grafting using cardiopulmonary bypass
You may qualify if:
- Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
- Patients from 18 to 85 years old.
You may not qualify if:
- Patients incapable to consent.
- Known coagulopathies or platelet dysfunction.
- Patients treated with antiplatelet drugs other than aspirin.
- Patients treated with anti vitamine K anticoagulants.
- Patients treated with heparin less than 6 hours prior to surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Gronchi F, Perret A, Ferrari E, Marcucci CM, Fleche J, Crosset M, Schoettker P, Marcucci C. Validation of rotational thromboelastometry during cardiopulmonary bypass: A prospective, observational in-vivo study. Eur J Anaesthesiol. 2014 Feb;31(2):68-75. doi: 10.1097/EJA.0b013e328363171a.
PMID: 23867776DERIVED
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo E Marcucci, MD
University of Lausanne Hospitals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 20, 2011
Record last verified: 2011-10