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ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674684
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Durila Miroslav MUDr. Ph.D., University Hospital, Motol

Tracking Information
First Submitted Date September 14, 2018
First Posted Date September 17, 2018
Last Update Posted Date September 19, 2018
Actual Study Start Date September 14, 2017
Actual Primary Completion Date July 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2018)
thromboelastometry assessment of coagulation [ Time Frame: 3 months ]
ROTEM tests- clotting time in seconds, Maximal clot firmness in mm, alpha angle of in degree of following tests EXTEM, INTEM, FIBTEM
Original Primary Outcome Measures
 (submitted: September 14, 2018)
thromboelastometry assessment of coagulation [ Time Frame: 1 month ]
ROTEM tests- EXTEM, INTEM, FIBTEM
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
Official Title Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo
Brief Summary Modern crystalloid and colloid solutions are balanced solutions which are increasingly used in perioperative period. However, studies investigating their negative effect on whole blood coagulation are missing. The aim of our study was to assess the effect of modern balanced crystalloid and colloid solutions on whole blood coagulation in vivo using rotational thromboelastometry.
Detailed Description Blood samples were obtained from 30 patients during knee arthroscopy before and after administration of 500 ml of modern balanced crystalloid, hydroxyethyl starch (HES) or gelatin. Rotational thromboelastometry (EXTEM, INTEM and FIBTEM tests) were performed to assess negative effect of fluid solutions on whole blood coagulation.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population healthy patients undergoing knee arthroscopy
Condition Coagulopathy
Intervention Other: hydroxyethyl starch
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids
Study Groups/Cohorts
  • hydroxyethyl starch
    Patients who received hydroxyethyl starch
    Intervention: Other: hydroxyethyl starch
  • gelatin
    Patients who received gelatin
    Intervention: Other: hydroxyethyl starch
  • crystalloids
    Patients who received crystalloids
    Intervention: Other: hydroxyethyl starch
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 Completed
Actual Enrollment
 (submitted: September 14, 2018)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date August 14, 2018
Actual Primary Completion Date July 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy patients undergoing knee arthroscopy

Exclusion Criteria:

  • receiving antiplatelet drugs
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03674684
Other Study ID Numbers 14092018 Motol Hospital
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
Plan to Share IPD: No
Responsible Party Durila Miroslav MUDr. Ph.D., University Hospital, Motol
Study Sponsor University Hospital, Motol
Collaborators Not Provided
Investigators
Principal Investigator: Miroslav Durila Second Medical Faculty, Charles University and University Hospital Motol
PRS Account University Hospital, Motol
Verification Date September 2018