Dilutional CoagulopathyNCT01727830
Hemodilution and Coagulopathy With 3 Colloids
An observational study of Dilutional Coagulopathy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dilutional Coagulopathy
- What is being tested?
- Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Nov 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: volunteers
Who may be able to join
- signed informed consent from before blood withdrawal
Who cannot join
- known coagulation disorders,
- any form of anticoagulation therapy,
- use of acetyl-salicylic acid within the past five days,
- use of non-steroidal anti-inflammatory agents within the past 24 hours,
- known renal disease or plasma concentrations of aspartate aminotransferase (>50 U l -1) or alanine aminotransferase (>50 U l-1)
- patients incapable of understanding the German language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Influence of Hemodilution on Coagulation, pH, Platelet Function, Laboratory Values and ROTEM in Volunteers Using HES 6%, Gelatine and Balanced Gelatine and the Reversal of Coagulopathy With F XIII and Fibrinogen
Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII.
In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed.
- Trial with medical device
- Conditions
- Dilutional Coagulopathy
- Being tested
- Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)Other
Also called This trial is in vitro and made with blood of healthy volunteers., Thus no drug no intervention beside drawing blood is beeing performed.
Blood drawn from volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversibility of in vitro induced coagulopathy
Coagulopathy in vitro measured after 60 % dilution with HES, Gelatin and Gelatin balanced. Addition of fibrinogen and factor XIII as well as their combination and measurement if the coagulopathy was corrected.
Measured: Same day when blood was drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilutional 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Theusinger, MD, Principal investigator, University Hospital Zurich, Division of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727830
- Sponsor's protocol ID
- KEK-ZH-Nr. 2012-0042
- Status last verified
- Nov 2012
- First submitted
- 5 Nov 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hemodilution on Coagulation, pH, Platelet Function, Laboratory Values and ROTEM in Volunteers Using HES 6%, Gelatine and Balanced Gelatine and the Reversal of Coagulopathy With F XIII and Fibrinogen
- ClinicalTrials.gov ID
- NCT01727830
- Acronym / sponsor ID
- KEK-ZH-Nr. 2012-0042
- Conditions
- Dilutional Coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Nov 2012 (estimated)
- 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.
Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII.
In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed.
- Trial with medical device
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- volunteers
Key inclusion criteria (1 listed)
- signed informed consent from before blood withdrawal
Key exclusion criteria (6 listed)
- known coagulation disorders,
- any form of anticoagulation therapy,
- use of acetyl-salicylic acid within the past five days,
- use of non-steroidal anti-inflammatory agents within the past 24 hours,
- known renal disease or plasma concentrations of aspartate aminotransferase (>50 U l -1) or alanine aminotransferase (>50 U l-1)
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 |
|---|---|---|
| Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)Also: This trial is in vitro and made with blood of healthy volunteers., Thus no drug no intervention beside drawing blood is beeing performed.Blood drawn from volunteers | Other | – |
Primary outcome
Reversibility of in vitro induced coagulopathy
Time frame: Same day when blood was drawn
Coagulopathy in vitro measured after 60 % dilution with HES, Gelatin and Gelatin balanced. Addition of fibrinogen and factor XIII as well as their combination and measurement if the coagulopathy was corrected.
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 16 Nov 2012.
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.
Oliver Theusinger, MD principal investigator
University Hospital Zurich, Division of Anaesthesiology
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 Dilutional Coagulopathy, run by University of Zurich at 1 site in Switzerland.
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 6 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 16 Nov 2012. 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 Switzerland. 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?
Reversibility of in vitro induced coagulopathy (time frame: Same day when blood was drawn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2012.