AnemiaPlethNCT01602978
Comparison of Pulse Hemoglobin and Pleth Variability Index
An observational study of Anemia and Fluid Management, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Fluid Management
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 13 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.
Who may be able to join
- Subjects must be >18 years old;
- must be having a major surgical procedure;
- The pre-operative estimation of blood loss must be at least 15% of the total blood volume
Who cannot join
- Does subject have hemoglobinopathy;
- cardiac arrhythmias producing irregular rhythms;
- severe pulmonary disease;
- procedures where loss of more that 10 to 15% of total blood volume is unlikely;
- subject refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.
The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.
- Conditions
- Anemia, Fluid Management
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between hemoglobin values from the two monitors.
The primary outcome measure is the difference between hemoglobin values from the pulse oximetry device and from the arterial blood gas co-oximeter.
Measured: Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.
Secondary outcomes (1)
Difference between measures compared to patient characteristics
Secondary outcome measures are the size of difference between measures compared to patient characteristics.
Measured: Start of surgery to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startFeb 2010
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Labs
- Responsible party
- Principal investigator, Davinder Ramsingh, MD, Loma Linda University
- Investigators
- Davinder Ramsingh, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602978
- Sponsor's protocol ID
- 5100032
- Acronym
- Pleth
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2012
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.
- ClinicalTrials.gov ID
- NCT01602978
- Acronym / sponsor ID
- Pleth / 5100032
- Conditions
- Anemia, Fluid Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Masimo Labs
- Study start
- Feb 2010
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 21 May 2012 (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.
The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.
Key inclusion criteria (3 listed)
- Subjects must be >18 years old;
- must be having a major surgical procedure;
- The pre-operative estimation of blood loss must be at least 15% of the total blood volume
Key exclusion criteria (5 listed)
- Does subject have hemoglobinopathy;
- cardiac arrhythmias producing irregular rhythms;
- severe pulmonary disease;
- procedures where loss of more that 10 to 15% of total blood volume is unlikely;
- subject refusal
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
The difference between hemoglobin values from the two monitors.
Time frame: Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.
The primary outcome measure is the difference between hemoglobin values from the pulse oximetry device and from the arterial blood gas co-oximeter.
1 secondary outcome
Difference between measures compared to patient characteristics
Time frame: Start of surgery to end of surgery
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 4 Mar 2019.
Related trials for Anemia
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes
Bone Marrow Failure Syndromes, Aplastic Anemias
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 1
F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
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.
Davinder Ramsingh, MD principal investigator
Loma Linda University
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 Anemia and Fluid Management, run by Loma Linda University at 1 site in United States.
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 5 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 4 Mar 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 United States. 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?
The difference between hemoglobin values from the two monitors. (time frame: Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.). 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 4 Mar 2019.