CoagulopathyNCT03674684
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
An observational study of Coagulopathy, run by University Hospital, Motol at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulopathy
- What is being tested?
- hydroxyethyl starch
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Sep 2017to 14 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy patients undergoing knee arthroscopy
Who may be able to join
- healthy patients undergoing knee arthroscopy
Who cannot join
- receiving antiplatelet drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coagulopathy
- Being tested
- hydroxyethyl starch
- Keywords
- hydroxyethyl starch, gelatin, ROTEM, coagulation
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyethyl starchOther
After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids
| Study group | Role | What they receive |
|---|---|---|
| hydroxyethyl starch | Patients who received hydroxyethyl starch Receives: Other: hydroxyethyl starch | |
| gelatin | Patients who received gelatin Receives: Other: hydroxyethyl starch | |
| crystalloids | Patients who received crystalloids Receives: Other: hydroxyethyl starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start14 Sep 2017
- Primary completion14 Jul 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
- Investigators
- Miroslav Durila, Principal investigator, Second Medical Faculty, Charles University and University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674684
- Sponsor's protocol ID
- 14092018 Motol Hospital
- Status last verified
- Feb 2025
- First submitted
- 14 Sep 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31405567
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo
- ClinicalTrials.gov ID
- NCT03674684
- Acronym / sponsor ID
- 14092018 Motol Hospital
- Conditions
- Coagulopathy
- Keywords
- hydroxyethyl starch, gelatin, ROTEM, coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydroxyethyl starch | – | Other: hydroxyethyl starchPatients who received hydroxyethyl starch |
| gelatin | – | Other: hydroxyethyl starchPatients who received gelatin |
| crystalloids | – | Other: hydroxyethyl starchPatients who received crystalloids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy patients undergoing knee arthroscopy
Key inclusion criteria (1 listed)
- healthy patients undergoing knee arthroscopy
Key exclusion criteria (1 listed)
- receiving antiplatelet drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxyethyl starchAfter induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids | Other | crystalloids, gelatin, hydroxyethyl starch |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 31405567Sevcikova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Durila principal investigator
Second Medical Faculty, Charles University and University Hospital Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thromboelastometry assessment of coagulation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.