Post Operative HemorrhageNCT04388722
Monitoring Noninvasively for Infusion and Transfusion Optimization
A study testing Pulse CO-Oximeter Sensor in people with Post Operative Hemorrhage and Transfusion Related Complication, run by Masimo Corporation.
Trial summary
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions
- What is being tested?
- Pulse CO-Oximeter Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older at the time of consent.
- Ability to provide written informed consent.
- Scheduled for non-urgent major surgery with general anesthesia
- At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
- The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.
Who cannot join
- Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
- Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
- Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
- Surgeries performed in the prone position.
- Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
- Aortic pathology that could lead to misinterpretation of hemodynamic variables (e.g. intra- aortic balloon pump, thoracic aorta aneurysm).
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- Renal vascular surgery.
- Preoperative sepsis.
- Circulatory shock.
- Preoperative vasoactive substance infusion before study entry.
- Concurrent participation in any interventional study.
- Pregnant or lactating women.
- Patients who refuse to receive blood transfusion(s).
- Patients with Do Not Resuscitate (DNR) orders.
- Open chest surgeries.
- Prisoners
- Patients for whom monitoring of CO, SV, PPV, and/or SVV to guide GDT or similar intra-operative fluid management, including continuous SpHb monitoring, would be standard of care.
- Patients have skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors.
- Cardio-pulmonary bypass (CPB) surgery.
About this study
Official title: Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
- Conditions
- Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions, Hypovolemia
- Being tested
- Pulse CO-Oximeter Sensor
- Medical subject headings
- Postoperative Hemorrhage, Transfusion Reaction, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse CO-Oximeter SensorDevice
Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi).
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Not described |
| Investigational Arm | Experimental | Not described Receives: Device: Pulse CO-Oximeter Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complication
Occurrence of at least one post-operative complication by day 7 after surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: Sponsor's decision to withdraw study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative HemorrhageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388722
- Sponsor's protocol ID
- MONITOR
- Status last verified
- Jul 2021
- First submitted
- 12 May 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial
- ClinicalTrials.gov ID
- NCT04388722
- Acronym / sponsor ID
- MONITOR
- Conditions
- Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions, Hypovolemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision to withdraw study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 14 May 2020 (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.
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | – |
| Investigational Arm | Experimental | Device: Pulse CO-Oximeter Sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older at the time of consent.
- Ability to provide written informed consent.
- Scheduled for non-urgent major surgery with general anesthesia
- At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
- The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.
Key exclusion criteria (19 listed)
- Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
- Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
- Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
- Surgeries performed in the prone position.
- Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
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 |
|---|---|---|
| Pulse CO-Oximeter SensorInvestigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi). | Device | Investigational Arm |
Primary outcome
Post-operative complication
Time frame: 7 days
Occurrence of at least one post-operative complication by day 7 after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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?
A study testing Pulse CO-Oximeter Sensor in people with Post Operative Hemorrhage and Transfusion Related Complication, run by Masimo Corporation.
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 5 inclusion and 19 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: withdrawn, as of the sponsor's last update on 23 Jul 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Post-operative complication (time frame: 7 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 23 Jul 2021.