Blood LossNCT03516552
Comparison and Analysis of Blood Loss Formulas
An observational study of Blood Loss, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Blood Loss
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 10 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients electively scheduled for laparoscopic surgery.
Who may be able to join
- Adults 18 - 90 yrs.
Who cannot join
- Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
- Surgical blood loss volume < 200 ml.
- Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
- Transfusion of red blood cells (RBCs) during the perioperative period.
- Significant postoperative bleeding (> 50 ml in surgical drains) or any other type of significant blood loss.
- Fluid infusions or vasoactive drugs after the first 24 postoperative hours.
Trial locations and contacts
1 site in 1 country.
About this study
Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.
- Conditions
- Blood Loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin content on blood loss | Hemoglobin content on blood loss, to assess ratio hemoglobin/volume. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences on blood loss estimation.
Measured: 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jan 2018
- Primary completion30 Jul 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (actual)
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
- NCT03516552
- Sponsor's protocol ID
- 2016/0906
- Status last verified
- Aug 2019
- First submitted
- 15 Apr 2018
- Last updated
- 7 Aug 2019
- 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 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison and Analysis of Blood Loss Formulas
- ClinicalTrials.gov ID
- NCT03516552
- Acronym / sponsor ID
- 2016/0906
- Conditions
- Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 4 May 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.
Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin content on blood loss | – | –Hemoglobin content on blood loss, to assess ratio hemoglobin/volume. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients electively scheduled for laparoscopic surgery.
Key inclusion criteria (1 listed)
- Adults 18 - 90 yrs.
Key exclusion criteria (6 listed)
- Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
- Surgical blood loss volume < 200 ml.
- Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
- Transfusion of red blood cells (RBCs) during the perioperative period.
- Significant postoperative bleeding (> 50 ml in surgical drains) or any other type of significant blood loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences on blood loss estimation.
Time frame: 72 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 7 Aug 2019.
- 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.
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 Blood Loss, 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 7 Aug 2019. 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?
Differences on blood loss estimation. (time frame: 72 hours.). 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 7 Aug 2019.