Blood Loss, SurgicalNCT03249038
Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
An observational study of Blood Loss, Surgical and Blood Loss, run by Hospital Clinic of Barcelona.
Trial summary
Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss, Blood Loss, Postoperative
- What is being tested?
- Measurement of external blood loss and Serum Hemoglobin concentration
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Sep 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective urologic laparoscopy surgery.
Who may be able to join
- Patients scheduled for elective urologic laparoscopy surgery.
Who cannot join
- Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
- Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
- Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.
About this study
Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.
- Conditions
- Blood Loss, Surgical, Blood Loss, Blood Loss, Postoperative
- Being tested
- Measurement of external blood loss, Serum Hemoglobin concentration
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of external blood lossOther
Serum Hemoglobin concentrationDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin mass lost
Measured: Intraoperative
Postoperative serum hemoglobin concentration
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Aug 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- NCT03249038
- Sponsor's protocol ID
- HCB/2016/0906
- Status last verified
- Oct 2024
- First submitted
- 10 Aug 2017
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
- ClinicalTrials.gov ID
- NCT03249038
- Acronym / sponsor ID
- HCB/2016/0906
- Conditions
- Blood Loss, Surgical, Blood Loss, Blood Loss, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 15 Aug 2017 (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.
Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective urologic laparoscopy surgery.
Key inclusion criteria (1 listed)
- Patients scheduled for elective urologic laparoscopy surgery.
Key exclusion criteria (3 listed)
- Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
- Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
- Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of external blood loss | Other | – |
| Serum Hemoglobin concentration | Diagnostic test | – |
Primary outcome
Hemoglobin mass lost
Time frame: Intraoperative
Postoperative serum hemoglobin concentration
Time frame: 48 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: 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Surgical and Blood Loss, run by Hospital Clinic of Barcelona.
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 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: 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.
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 mass lost (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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.