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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

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.

Condition or disease Intervention/treatment
Coagulopathy Other: hydroxyethyl starch

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : July 14, 2018
Actual Study Completion Date : August 14, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
hydroxyethyl starch
Patients who received hydroxyethyl starch
Other: hydroxyethyl starch
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids

gelatin
Patients who received gelatin
Other: hydroxyethyl starch
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids

crystalloids
Patients who received crystalloids
Other: hydroxyethyl starch
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy patients undergoing knee arthroscopy
Criteria

Inclusion Criteria:

  • healthy patients undergoing knee arthroscopy

Exclusion Criteria:

  • receiving antiplatelet drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674684


Locations
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Czechia
Miroslav Durila
Prague, Praha, Hlavní Město, Czechia, 15006
Sponsors and Collaborators
University Hospital, Motol
Investigators
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Principal Investigator: Miroslav Durila Second Medical Faculty, Charles University and University Hospital Motol
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Responsible Party: Durila Miroslav MUDr. Ph.D., associated professor, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT03674684    
Other Study ID Numbers: 14092018 Motol Hospital
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durila Miroslav MUDr. Ph.D., University Hospital, Motol:
hydroxyethyl starch, gelatin, ROTEM, coagulation
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders