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NCT03674684 Clinical Trial

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

Coagulopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03674684
Other study ID # 14092018 Motol Hospital
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2017
Est. completion date August 14, 2018

Study information
Verified date September 2018
Source University Hospital, Motol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 14, 2018
Est. primary completion date July 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- healthy patients undergoing knee arthroscopy

Exclusion Criteria:

- receiving antiplatelet drugs

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Czechia Miroslav Durila Prague Praha, Hlavní Mesto

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary thromboelastometry assessment of coagulation ROTEM tests- clotting time in seconds, Maximal clot firmness in mm, alpha angle of in degree of following tests EXTEM, INTEM, FIBTEM 3 months
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