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Thromboelastometry in Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03011827
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Annabel Blasi, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Red blood cell transfusion [ Time Frame: until 24h after liver transplant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Thrombosis [ Time Frame: 28 days after liver transplant ]
Thrombosis will be assessed clinically and confirmed by ultrasonographic exam
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
Thrombosis [ Time Frame: 28 days after liver transplant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thromboelastometry in Liver Transplantation
Official Title  ICMJE Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.
Brief Summary Thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ; suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product administration. The aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Transplant Disorder
  • Coagulopathy
Intervention  ICMJE Other: Fibrinogen and/or platelets administration
Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure
Study Arms  ICMJE Experimental: Prospective cohort
Fibrinogen and/or platelet administration
Intervention: Other: Fibrinogen and/or platelets administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2017)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presurgical hemoglobin < 13 d/L and clot firmness at 10 minutes Extem < 35 mm

Exclusion Criteria:

  • Previous thrombosis
  • Antithrombotic treatment
  • No consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annabel Blasi, MD, PhD +34679500857 ablasi@clinic.ub.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011827
Other Study ID Numbers  ICMJE ATR100F
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Annabel Blasi, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annabel Blasi, MD, PhD Hospital Clinic Barcelona. IDIBAPS
PRS Account Hospital Clinic of Barcelona
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP