HemorrhageNCT02980471
Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume
An observational study of Hemorrhage, run by Flashback Technologies.
Trial summary
The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index (CRI) numeric and graphical trend readings to intravascular volume changes as compared to graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to stroke volume as measured by the Nexfin… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Twenty healthy volunteers between the ages of 18 and 55, men and women, American Society of Anesthesiology "class 1" health status.
Who may be able to join
- • Ages 18-55.
- Physical status: Healthy ASA Class 1.
- Male or female.
- Screening hemoglobin > 13.5 g/dl and hematocrit > 39% for males
- Screening hemoglobin > 12 g/dl and hematocrit > 35% for females
- BMI <30
- Ability to provide written informed consent.
- Willing and able to comply with study procedures
Who cannot join
- • Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
- Subjects with history of cardiovascular disease, hypertension, diabetes or any other diseases/conditions that might negatively influence their ability to tolerate moderate but temporary blood loss.
- Obese subjects (BMI>30)
- Smoker.
- Subjects on drugs of any type (except oral contraceptives).
- Female subjects that are actively trying to get pregnant or are pregnant.
- Subjects taking blood thinners or medications with antiplatelet factors.
About this study
The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index (CRI) numeric and graphical trend readings to intravascular volume changes as compared to graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to stroke volume as measured by the Nexfin monitor during the same graded blood removal period. Enrollment includes both men and women.
Read the detailed description
Sequential Blood Loss: Blood loss will be simulated by withdrawal of 20% of estimated total blood volume. Estimated total blood volume for men = 75 mL/kg and for women = 65 mL/kg. The calculated target withdrawal volume is also consistent with an allowable estimated blood loss equation assuming a starting hematocrit (hct) of approximately 45% in males and 40% in females, where the expected drop in hct for this volume withdrawn is 7 percentage points in males and 6 percentage points in females. An actual drop in hct may not be observed in this study due to the relatively expedient removal of blood and no simultaneous administration of fluids (i.e., no "hemodilution" with crystalloid). Blood will be removed in aliquots up to ~333 mL. For safety, men will have no more than 4 units of blood removed (1,333 mL) and women will have no more than 3 units of blood removed (1,000 mL).
The blood will be withdrawn via the venous catheter and we anticipate that it will take 15-20 min for each stage of blood withdrawal to occur. A total of 3 aliquots will be withdrawn over approximately sixty minutes in women and 4 aliquots withdrawn over 80 minutes in men. The blood will be stored using preservatives and anticoagulation procedures similar to those used for perioperative hemodilution and/or intraoperative cell saver. The blood will remain in the study room until it is re-infused. We will use standard "auto-transfusion" blood collection equipment identical to that used in the ORs for perioperative hemodilution techniques. The blood will be drained by gravity from an indwelling vascular catheter into anti-coagulant preservative solution using tubing and bags systems provided by the autologous transfusion team that we routinely work with in the ORs. For the first several studies we will schedule them at a time when auto-transfusion OR personnel can be present and after that the anesthesiologists will be directly involved in drawing the blood, subsequent handling and reinfusion. The blood will never leave the autologous transfusion bag and a closed system will be used. The blood will be held at room temp with gentle agitation for ~60-80 minutes and then re-infused over 60-80 minutes via a large bore IV; monitoring will continue during reinfusion. Following completion of the reinfusion subjects will de-instrumented and observed in the physiology lab for two hours.
- Conditions
- Hemorrhage
- Being tested
- Pulse Oximeter
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximeterDevice
Blood removal and reintroduction as measured by the plethysmograph of a pulse oximeter
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of CipherOx trend to blood removal for trending intravascular volume
comparison of CipherOx reading trend before removal of blood, post 330mL, 660mL and 1,000mL blood removal for trending intravascular volume change
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flashback Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980471
- Sponsor's protocol ID
- Pro00049209
- Status last verified
- Dec 2016
- First submitted
- 30 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume
- ClinicalTrials.gov ID
- NCT02980471
- Acronym / sponsor ID
- Pro00049209
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Flashback TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Dec 2016 (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 demonstrate the correlation of the Compensatory Reserve Index (CRI) numeric and graphical trend readings to intravascular volume changes as compared to graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to stroke volume as measured by the Nexfin monitor during the same graded blood removal period. Enrollment includes both men and women.
Detailed description
Sequential Blood Loss: Blood loss will be simulated by withdrawal of 20% of estimated total blood volume. Estimated total blood volume for men = 75 mL/kg and for women = 65 mL/kg. The calculated target withdrawal volume is also consistent with an allowable estimated blood loss equation assuming a starting hematocrit (hct) of approximately 45% in males and 40% in females, where the expected drop in hct for this volume withdrawn is 7 percentage points in males and 6 percentage points in females. An actual drop in hct may not be observed in this study due to the relatively expedient removal of blood and no simultaneous administration of fluids (i.e., no "hemodilution" with crystalloid). Blood will be removed in aliquots up to ~333 mL. For safety, men will have no more than 4 units of blood removed (1,333 mL) and women will have no more than 3 units of blood removed (1,000 mL).
The blood will be withdrawn via the venous catheter and we anticipate that it will take 15-20 min for each stage of blood withdrawal to occur. A total of 3 aliquots will be withdrawn over approximately sixty minutes in women and 4 aliquots withdrawn over 80 minutes in men. The blood will be stored using preservatives and anticoagulation procedures similar to those used for perioperative hemodilution and/or intraoperative cell saver. The blood will remain in the study room until it is re-infused. We will use standard "auto-transfusion" blood collection equipment identical to that used in the ORs for perioperative hemodilution techniques. The blood will be drained by gravity from an indwelling vascular catheter into anti-coagulant preservative solution using tubing and bags systems provided by the autologous transfusion team that we routinely work with in the ORs. For the first several studies we will schedule them at a time when auto-transfusion OR personnel can be present and after that the anesthesiologists will be directly involved in drawing the blood, subsequent handling and reinfusion. The blood will never leave the autologous transfusion bag and a closed system will be used. The blood will be held at room temp with gentle agitation for ~60-80 minutes and then re-infused over 60-80 minutes via a large bore IV; monitoring will continue during reinfusion. Following completion of the reinfusion subjects will de-instrumented and observed in the physiology lab for two hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty healthy volunteers between the ages of 18 and 55, men and women, American Society of Anesthesiology "class 1" health status.
Key inclusion criteria (8 listed)
- • Ages 18-55.
Key exclusion criteria (8 listed)
- • Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test
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 OximeterBlood removal and reintroduction as measured by the plethysmograph of a pulse oximeter | Device | – |
Primary outcome
Comparison of CipherOx trend to blood removal for trending intravascular volume
Time frame: 1 hour
comparison of CipherOx reading trend before removal of blood, post 330mL, 660mL and 1,000mL blood removal for trending intravascular volume change
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 2 Dec 2016.
- 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 Hemorrhage, run by Flashback Technologies.
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 8 inclusion and 8 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 2 Dec 2016. 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?
Comparison of CipherOx trend to blood removal for trending intravascular volume (time frame: 1 hour). 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 2 Dec 2016.