Blood Loss, SurgicalNCT05316649
Blood Loss Quantification During Major Abdominal Surgery
An observational study of Blood Loss, Surgical and Blood Loss, Postoperative, run by University of Defence, Faculty of Military Health Sciences at 1 site in Czechia.
Trial summary
Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Complications
- What is being tested?
- Measurement of external blood loss and Serum Hemoglobin concentration
- How many people
- 45 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2021to 31 Aug 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing for elective liver or pancreas surgery.
Who may be able to join
- patient scheduled for liver or pancreatic surgery
- age of patient ≥ 18 years
- signed informed consent provided
Who cannot join
- patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants).
- use of cell saver suctioning during operation
- damage/clotting of blood samples
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University of Defence, Faculty of Military Health Sciences
Hradec Králové, 50001
Jan Zajak, MD, MA, jan.zajak@fnhk.cz
About this study
Official title: Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.
Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.
- Being tested
- Measurement of external blood loss, Serum Hemoglobin concentration
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of external blood lossOther
Measurement of external blood loss
Serum Hemoglobin concentrationDiagnostic test
Serum Hemoglobin concentration
| Study group | Role | What they receive |
|---|---|---|
| HPB group | Adult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic. Receives: Other: Measurement of external blood loss; Diagnostic Test: Serum Hemoglobin concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loos quantification
Estimated blood loss by surgeon (sEBL) Estimated blood loss by anesthesiologist (aEBL) Gravimetric blood loss weighted (vGBL) Calculated blood loos based on anthropometric and hematological parameters (vCBL) Spectrophotometric measured hemoglobin mass loss (hbMBL) Measured blood loss using using hbMBL and patient's average pre- and postoperative serum hemoglobin (vMBL)
Measured: 1 year
Secondary outcomes (1)
Postoperative complications
The effect of blood loss measured by spectrophotometric method on postoperative complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
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 Blood Loss, SurgicalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Defence, Faculty of Military Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Responsible party
- Principal investigator, Jan Zajak, University of Defence, Faculty of Military Health Sciences
- Investigators
- Jan Zajak, MD, MA, Principal investigator, University of Defence, Faculty of Military Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316649
- Sponsor's protocol ID
- BloodMO0FVZ0000503
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zajak J, Paral J, Sirovy M, Odlozilova S, Vinklerova K, Lochman P, Cecka F. Blood loss quantification during major abdominal surgery: prospective observational cohort study. BMC Surg. 2024 Jan 2;24(1):5. doi: 10.1186/s12893-023-02288-w.
PubMed 38166991
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.
- ClinicalTrials.gov ID
- NCT05316649
- Acronym / sponsor ID
- BloodMO0FVZ0000503
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Defence, Faculty of Military Health SciencesUniversity, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 7 Apr 2022 (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.
Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPB group | – | Other: Measurement of external blood loss, Diagnostic Test: Serum Hemoglobin concentrationAdult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing for elective liver or pancreas surgery.
Key inclusion criteria (3 listed)
- patient scheduled for liver or pancreatic surgery
- age of patient ≥ 18 years
- signed informed consent provided
Key exclusion criteria (3 listed)
- patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants).
- use of cell saver suctioning during operation
- damage/clotting of blood samples
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 |
|---|---|---|
| Measurement of external blood lossMeasurement of external blood loss | Other | HPB group |
| Serum Hemoglobin concentrationSerum Hemoglobin concentration | Diagnostic test | HPB group |
Primary outcome
Blood loos quantification
Time frame: 1 year
Estimated blood loss by surgeon (sEBL) Estimated blood loss by anesthesiologist (aEBL) Gravimetric blood loss weighted (vGBL) Calculated blood loos based on anthropometric and hematological parameters (vCBL) Spectrophotometric measured hemoglobin mass loss (hbMBL) Measured blood loss using using hbMBL and patient's average pre- and postoperative serum hemoglobin (vMBL)
1 secondary outcome
Postoperative complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 38166991Zajak J, Paral J, Sirovy M, Odlozilova S, Vinklerova K, Lochman P, Cecka F. Blood loss quantification during major abdominal surgery: prospective observational cohort study. BMC Surg. 2024 Jan 2;24(1):5. doi: 10.1186/s12893-023-02288-w.
- 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.
Jan Zajak, MD, MA principal investigator
University of Defence, Faculty of Military Health Sciences
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 Blood Loss, Surgical and Blood Loss, Postoperative, run by University of Defence, Faculty of Military Health Sciences 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Zajak, MD, MA (00420495833620, jan.zajak@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loos quantification (time frame: 1 year). 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 NCT05316649, 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 7 Apr 2022.