Surgical Blood LossNCT03740438
Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
An observational study of Surgical Blood Loss and Surgery, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Blood Loss, Surgery, Perioperative/Postoperative Complications
- What is being tested?
- Hemoglobin concentration
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 2 Sep 2023
- How long will I take part?
- 4 Days
- 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 electively scheduled for laparoscopic urologic and gynecologic surgery.
Who may be able to join
- Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.
Who cannot join
- Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
- Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
- Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period.
- Significant postoperative bleeding (> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss).
- Postoperative hemodynamic instability (defined as requirement of vasoactive drugs).
- Other major postoperative complications during the observable period.
Trial locations and contacts
1 site in 1 country.
About this study
transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.
- Being tested
- Hemoglobin concentration
- Keywords
- Hemoglobin, Hemoglobin drop, Surgical Blood loss
- Medical subject headings
- Blood Loss, Surgical, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin concentrationDiagnostic test
Perioperative hemogloin concentration
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)
Measured: 2-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 154 participants (actual)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Jaramillo, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740438
- Sponsor's protocol ID
- HCB/2016/0906/2
- Status last verified
- Oct 2024
- First submitted
- 5 Nov 2018
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
- ClinicalTrials.gov ID
- NCT03740438
- Acronym / sponsor ID
- HCB/2016/0906/2
- Keywords
- Hemoglobin, Hemoglobin drop, Surgical Blood loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 14 Nov 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.
transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.
Key inclusion criteria (1 listed)
- Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.
Key exclusion criteria (6 listed)
- Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
- Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
- Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period.
- Significant postoperative bleeding (> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss).
- Postoperative hemodynamic instability (defined as requirement of vasoactive 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 |
|---|---|---|
| Hemoglobin concentrationPerioperative hemogloin concentration | Diagnostic test | – |
Primary outcome
Hemoglobin concentration
Time frame: 2-5 days
Patient´s hemoglobin concentration in the postoperative course (measured every 24 hours)
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 29 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Blood Loss and Surgery, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 29 Oct 2024. 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 Spain. 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?
Hemoglobin concentration (time frame: 2-5 days). 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 29 Oct 2024.