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

NCT ID: NCT03674684

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-14

Study Completion Date

2018-08-14

Brief Summary

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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

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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.

Conditions

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Coagulopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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hydroxyethyl starch

Patients who received hydroxyethyl starch

hydroxyethyl starch

Intervention Type OTHER

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

gelatin

Patients who received gelatin

hydroxyethyl starch

Intervention Type OTHER

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

crystalloids

Patients who received crystalloids

hydroxyethyl starch

Intervention Type OTHER

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

Interventions

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hydroxyethyl starch

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy patients undergoing knee arthroscopy

Exclusion Criteria

* receiving antiplatelet drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

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Durila Miroslav MUDr. Ph.D.

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miroslav Durila

Role: PRINCIPAL_INVESTIGATOR

Second Medical Faculty, Charles University and University Hospital Motol

Locations

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University Hopital Motol

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 31405567 (View on PubMed)

Other Identifiers

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14092018 Motol Hospital

Identifier Type: -

Identifier Source: org_study_id

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