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

September 17, 2018 updated by: Durila Miroslav MUDr. Ph.D., University Hospital, Motol

Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Praha, Hlavní Město
      • Prague, Praha, Hlavní Město, Czechia, 15006
        • Miroslav Durila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

healthy patients undergoing knee arthroscopy

Description

Inclusion Criteria:

  • healthy patients undergoing knee arthroscopy

Exclusion Criteria:

  • receiving antiplatelet drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Investigators

  • Principal Investigator: Miroslav Durila, Second Medical Faculty, Charles University and University Hospital Motol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2017

Primary Completion (Actual)

July 14, 2018

Study Completion (Actual)

August 14, 2018

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14092018 Motol Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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