Patient SafetyNCT04184570
Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
An observational study of Patient Safety and Patient Blood Management, run by Dr. Florian Piekarski at 1 site in Germany.
Trial summary
The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Safety, Patient Blood Management
- What is being tested?
- Observational Trial
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 16 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: International anesthetic records
Who may be able to join
- Anesthetic records
Who cannot join
- Incomplete records
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
Frankfurt, North Rhine-Westphalia, 60598
About this study
The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.
Read the detailed description
The anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. Records vary in content and design. Several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose.
Anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. Disagreements will be resolved by a the principle investigator.
- Conditions
- Patient Safety, Patient Blood Management
- Being tested
- Observational Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational TrialOther
Observational Trial
What is being measured
The primary outcome is the main question the study is designed to answer.
Contained items in anesthetic records
The main outcome measure are hemotherapy-items in anesthetic records
Measured: 11/01/2019 - 12/01/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Nov 2019
- Primary completion15 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies 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
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Florian Piekarski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Florian Piekarski, Johann Wolfgang Goethe University Hospital
- Investigators
- Florian Piekarski, Dr. med., Principal investigator, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184570
- Sponsor's protocol ID
- KGU_FP_2019_xCA2
- Status last verified
- Jan 2020
- First submitted
- 23 Nov 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
- ClinicalTrials.gov ID
- NCT04184570
- Acronym / sponsor ID
- KGU_FP_2019_xCA2
- Conditions
- Patient Safety, Patient Blood Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Dr. Florian PiekarskiUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 3 Dec 2019 (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.
The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.
Detailed description
The anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. Records vary in content and design. Several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose.
Anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. Disagreements will be resolved by a the principle investigator.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- International anesthetic records
Key inclusion criteria (1 listed)
- Anesthetic records
Key exclusion criteria (1 listed)
- Incomplete records
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 |
|---|---|---|
| Observational TrialObservational Trial | Other | – |
Primary outcome
Contained items in anesthetic records
Time frame: 11/01/2019 - 12/01/2019
The main outcome measure are hemotherapy-items in anesthetic records
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 28 Jan 2020.
- 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.
Florian Piekarski, Dr. med. principal investigator
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
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 Patient Safety and Patient Blood Management, run by Dr. Florian Piekarski at 1 site in Germany.
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 28 Jan 2020. 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 Germany. 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?
Contained items in anesthetic records (time frame: 11/01/2019 - 12/01/2019). 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 28 Jan 2020.