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Heparin's Influence on ROTEM® Analysis

This study has been completed.
Sponsor:
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01455454
First received: October 18, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary artery disease
patients undergoing coronary artery bypass grafting using cardiopulmonary bypass

Detailed Description:

The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac surgery have a blood transfusion.

Several studies indicate an increase in morbidity and mortality related to blood transfusions.

Traditionally, the coagulation tests are performed in the hematology laboratory.

Rotational thromboelastrometry is a useful method of assessing perioperative coagulation function in patients undergoing cardiac surgery.

The presence of significant amounts of heparin in blood samples during cardiopulmonary bypass induces artifactual errors when thromboplastin is used as a reagent. For this reason, whole blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary bypass with heparin anticoagulation. Recently recombinant thromboplastin has come available. It's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5UI/l .

Three of the available ROTEM®-tests are EXTEM (activation by recombinant thromboplastin), INTEM (activation by elagic acid) and HEPTEM. In the latter, heparinase, added to the INTEM reagent, eliminates heparin to reveal underlying coagulopathies.

The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high concentration of heparin and to evaluate whether heparinase could reverse heparin's effect on EXTEM and INTEM during cardiopulmonary bypass.

Arterial blood samples were drawn for analysis after induction of anesthesia (T0),10 minutes after the administration of heparin (T1), at unclamping of the aorta (T2) and after heparin reversal with protamine (T3). The following tests will be performed: EXTEM, INTEM, HEPTEM and a heparinase modified EXTEM. For the latter, recombinant thromboplatin instead of the elagic acid is used in the HEPTEM test. Heparin concentrations are measured at T1 and at the end of bypass (T2). HEPCON® was used for heparin management.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing coronary artery bypass grafting using cardiopulmonary bypass

Criteria

Inclusion Criteria:

  • Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
  • Patients from 18 to 85 years old.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455454

Locations
Switzerland
University of Lausanne Hospitals
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Carlo E Marcucci, MD University of Lausanne Hospitals
  More Information

No publications provided by University of Lausanne Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01455454     History of Changes
Other Study ID Numbers: 123/10
Study First Received: October 18, 2011
Last Updated: October 19, 2011
Health Authority: Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014