Undetected Intraoperative Blood LossNCT01864980
Intra-operative Monitoring of Blood Loss
An observational study of Undetected Intraoperative Blood Loss, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undetected Intraoperative Blood Loss
- What is being tested?
- blood transfusion, intermittent Hbsatlab measurement and blood transfusion, based on continuous SpHb readings
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to May 2014
- 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: 30 adult patients scheduled for surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss
Who may be able to join
- Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss.
- American Society of Anesthesiologists (ASA) classification I, II, III, IV
Who cannot join
- Patient refusal
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ
About this study
Official title: Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?
Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.
- Conditions
- Undetected Intraoperative Blood Loss
- Being tested
- blood transfusion, intermittent Hbsatlab measurement, blood transfusion, based on continuous SpHb readings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood transfusion, intermittent Hbsatlab measurementProcedure or surgery
In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
blood transfusion, based on continuous SpHb readingsProcedure or surgery
RBC administration and its timing will be based on continuous SpHb readings while Hbsatlab values, measured every 30 min. by an objective observer, will not be visible to the attending anaesthetist.
| Study group | Role | What they receive |
|---|---|---|
| Hb group:15 patients | scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss. Receives: Procedure: blood transfusion, intermittent Hbsatlab measurement | |
| SpHb group: 15 patients | scheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss. Receives: Procedure: blood transfusion, based on continuous SpHb readings |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbAUC
the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate
Measured: during operation
Secondary outcomes (1)
blood transfusions
the number of perioperative blood transfusions
Measured: intra- and post operative up to 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undetected Intraoperative Blood LossStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr.T.W.L.Scheeren, University Medical Center Groningen
- Investigators
- Michel M.R.F. Struys, Prof.dr, Principal investigator, University of groningen,University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864980
- Sponsor's protocol ID
- bleeding SpHb-001
- Status last verified
- May 2015
- First submitted
- 22 May 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?
- ClinicalTrials.gov ID
- NCT01864980
- Acronym / sponsor ID
- bleeding SpHb-001
- Conditions
- Undetected Intraoperative Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 May 2013 (estimated)
- 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.
Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hb group:15 patients | – | Procedure: blood transfusion, intermittent Hbsatlab measurementscheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss. |
| SpHb group: 15 patients | – | Procedure: blood transfusion, based on continuous SpHb readingsscheduled for elective surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 adult patients scheduled for surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss
Key inclusion criteria (2 listed)
- Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss.
- American Society of Anesthesiologists (ASA) classification I, II, III, IV
Key exclusion criteria (2 listed)
- Patient refusal
- Emergency surgery
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 |
|---|---|---|
| blood transfusion, intermittent Hbsatlab measurementIn the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care) | Procedure or surgery | Hb group:15 patients |
| blood transfusion, based on continuous SpHb readingsRBC administration and its timing will be based on continuous SpHb readings while Hbsatlab values, measured every 30 min. by an objective observer, will not be visible to the attending anaesthetist. | Procedure or surgery | SpHb group: 15 patients |
Primary outcome
HbAUC
Time frame: during operation
the total time a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate
1 secondary outcome
blood transfusions
Time frame: intra- and post operative up to 48h
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 27 May 2015.
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.
Michel M.R.F. Struys, Prof.dr principal investigator
University of groningen,University Medical Center Groningen
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 Undetected Intraoperative Blood Loss, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 2 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 27 May 2015. 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 Netherlands. 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?
HbAUC (time frame: during operation). 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 27 May 2015.