ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2018
CompletedFirst Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedFebruary 25, 2025
February 1, 2025
10 months
September 14, 2018
February 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
hydroxyethyl starch
Patients who received hydroxyethyl starch
gelatin
Patients who received gelatin
crystalloids
Patients who received crystalloids
Interventions
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids
Eligibility Criteria
healthy patients undergoing knee arthroscopy
You may qualify if:
- healthy patients undergoing knee arthroscopy
You may not qualify if:
- receiving antiplatelet drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hopital Motol
Prague, 15006, Czechia
Related Publications (1)
Sevcikova S, Durila M, Vymazal T. [Rotational thromboelastometry assessment of ballanced crystalloid, hydroxyethyl starch and gelatin effects on coagulation: a randomized trial]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):383-389. doi: 10.1016/j.bjan.2019.03.009. Epub 2019 Aug 9.
PMID: 31405567BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miroslav Durila
Second Medical Faculty, Charles University and University Hospital Motol
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associated professor
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 17, 2018
Study Start
September 14, 2017
Primary Completion
July 14, 2018
Study Completion
August 14, 2018
Last Updated
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share