Surgical Blood LossNCT03340116
Measurement of Blood Volume Loss During Burn Surgery
An observational study of Surgical Blood Loss and Burns, run by Virginia Commonwealth University.
Trial summary
Burn surgery is associated with significant reductions in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Blood Loss, Burns
- What is being tested?
- Burn surgery and Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-70 year old male or non-pregnant females who have sustained deep partial thickness to full thickness thermal burns between 10-50% TBSA who are undergoing burn surgery
Who may be able to join
- Sustained thermal burn of a depth that is deep partial thickness to full thickness and requires operative management
- Burn excision must occur within one week of thermal injury
- Burn size between 10-50% of total body surface area
- Must survive initial resuscitation
- Must consent for blood product transfusion
- Male or non-pregnant female
Who cannot join
- Cause of burn other than thermal injury (ie electrical or chemical injury)
- Women who are nursing, pregnant, or think they may be pregnant
- Patients with recognized coagulopathy
About this study
Official title: Measurement of Plasma Volume, RBC Volume, and Total Blood Volume Using Daxor Blood Volume Analyzer (BVA-100) in Burn Surgery Patients Pre-operatively and Post-operatively to Determine if Blood Loss During Burn Surgery is Primarily Due to Either Loss of RBC Volume or Hemodilution
Burn surgery is associated with significant reductions in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. The investigators will be using the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total blood volume, plasma volume, and RBC volume using the indicator dilution technique. By comparing pre-operative measurements of blood volume, plasma volume, and RBC volume to that of post-operative measurements after burn surgery, the investigators can determine the primary cause of the reduction in hematocrit associated with burn surgery. The investigators hypothesize that these reductions in hematocrit are primarily the result of hemodilution rather than blood loss and that there will be a statistically significant difference in measured plasma volume from the pre-operative group to the post-operative group.
Read the detailed description
Burn surgery is associated with significant changes (reductions) in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. The investigators will be using the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total blood volume, plasma volume, and RBC volume using the indicator dilution technique. With this technique, a tracer substance (I-131 albumin) is mixed with an unknown volume. An identical amount of the tracer is mixed into a solution with a known volume. By comparing the concentration of the indicator between the known and unknown volumes, the investigators can determine the volume of the unknown volume (or in this case, the blood volume).
The investigators will be measuring the change in blood volume, plasma volume, and RBC volume from the pre-operative to the post-operative state after completion of burn surgery. We hypothesize that these reductions in hematocrit are primarily the result of hemodilution rather than blood loss and that there will be a statistically significant change in measured plasma volume from the pre-operative to the post-operative measurements.
Average plasma volume for male and female patients is 2950ml SD=590 ml. To detect a 10% increase in plasma volume from hemodilution with a power 0.80 and alpha error 0.05, a one tailed normal distribution t-test determines a sample size fifty. To account for a 10% data loss (technical difficulty, patient withdraw) a sample size of fifty-five would be required.
Fifty-five consecutive adult patients (18 years or older) having burn surgery will be enrolled. Patients with recognized coagulopathy will be excluded. The outcome variables included blood volume (BV, ml), plasma volume (PV, ml) and red blood cell volume (RBCV, ml). All three outcome variables will be measured at two time points; pre-surgery and post-surgery. The pre-surgery measurement will be collected precisely after induction of general anesthesia but prior to surgery start. The post-surgery measurement will be taken immediately after the operation and after all intraoperative red blood cell transfusions are complete. For those patients receiving blood transfusions in the operating room prior to all data collection points, the transfused RBC volume will be recorded and subtracted from the RBCV measured after the transfusion. Transfused RBCV will take into account Hct of 60% for pRBCs. Additional baseline information, including age (year), sex (male, female), weight (kg), and surgery type, will be collected. For the tracer dilution method, the following blood samples will be collected: a baseline (no radiation sample), a first sample 12 minutes after injection (after complete mixing in the blood volume) and additional samples every 6 minutes for at least three successive timed sample points. These multiple timed sample points produce a logarithmic curve of radiation over time, as only a small fraction of albumin leaves the blood volume into the interstitial space. The investigators will compare the pre-operative and post-operative blood volume, RBC volume, and plasma volume measurements to determine if the decrease in hematocrit associated with burn surgery is truly due to hemodilution or loss of RBC volume.
- Conditions
- Surgical Blood Loss, Burns
- Being tested
- Burn surgery, Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100
- Medical subject headings
- Blood Loss, Surgical, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burn surgeryProcedure or surgery
Burn surgery including wound debridement, skin grafting
Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100Diagnostic test
Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative cohort | This cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 prior to any surgical intervention Receives: Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100 | |
| Post-operative cohort | This cohort will consist of the same study participants in the pre-operative cohort. The only difference is that this cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 AFTER burn surgery. Receives: Procedure: Burn surgery; Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured plasma volume
Measured plasma volume using Daxor BVA-100
Measured: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Change in measured RBC volume
Measured RBC volume using Daxor BVA-100
Measured: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Change in measured total blood volume
Measured total blood volume using Daxor BVA-100
Measured: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Unable to find any suitable patients to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Daxor Corporation
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, MD, Principal investigator, VCU Medical CenterMichael Feldman, MD, Principal investigator, VCU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340116
- Sponsor's protocol ID
- HM20015231
- Other IDs
- HM20011159
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers outside of the investigators listed in this study group.
Publications
Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. doi: 10.1016/j.burns.2005.09.005. Epub 2006 Jan 18.
PubMed 16414197Budny PG, Regan PJ, Roberts AH. The estimation of blood loss during burns surgery. Burns. 1993 Apr;19(2):134-7. doi: 10.1016/0305-4179(93)90036-8.
PubMed 8471147Meiser A, Casagranda O, Skipka G, Laubenthal H. [Quantification of blood loss. How precise is visual estimation and what does its accuracy depend on?]. Anaesthesist. 2001 Jan;50(1):13-20. doi: 10.1007/s001010050957. German.
PubMed 11220251CRISPELL KR, PORTER B, NIESET RT. Studies of plasma volume using human serum albumin tagged with radioactive iodine. J Clin Invest. 1950 May;29(5):513-6. doi: 10.1172/JCI102288. No abstract available.
PubMed 15415456Manzone TA, Dam HQ, Soltis D, Sagar VV. Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study. J Nucl Med Technol. 2007 Jun;35(2):55-63; quiz 77, 79. doi: 10.2967/jnmt.106.035972. Epub 2007 May 11.
PubMed 17496003
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Plasma Volume, RBC Volume, and Total Blood Volume Using Daxor Blood Volume Analyzer (BVA-100) in Burn Surgery Patients Pre-operatively and Post-operatively to Determine if Blood Loss During Burn Surgery is Primarily Due to Either Loss of RBC Volume or Hemodilution
- ClinicalTrials.gov ID
- NCT03340116
- Acronym / sponsor ID
- HM20015231
- Conditions
- Surgical Blood Loss, Burns
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to find any suitable patients to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Daxor Corporation
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 13 Nov 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.
Burn surgery is associated with significant reductions in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. The investigators will be using the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total blood volume, plasma volume, and RBC volume using the indicator dilution technique. By comparing pre-operative measurements of blood volume, plasma volume, and RBC volume to that of post-operative measurements after burn surgery, the investigators can determine the primary cause of the reduction in hematocrit associated with burn surgery. The investigators hypothesize that these reductions in hematocrit are primarily the result of hemodilution rather than blood loss and that there will be a statistically significant difference in measured plasma volume from the pre-operative group to the post-operative group.
Detailed description
Burn surgery is associated with significant changes (reductions) in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. The investigators will be using the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total blood volume, plasma volume, and RBC volume using the indicator dilution technique. With this technique, a tracer substance (I-131 albumin) is mixed with an unknown volume. An identical amount of the tracer is mixed into a solution with a known volume. By comparing the concentration of the indicator between the known and unknown volumes, the investigators can determine the volume of the unknown volume (or in this case, the blood volume).
The investigators will be measuring the change in blood volume, plasma volume, and RBC volume from the pre-operative to the post-operative state after completion of burn surgery. We hypothesize that these reductions in hematocrit are primarily the result of hemodilution rather than blood loss and that there will be a statistically significant change in measured plasma volume from the pre-operative to the post-operative measurements.
Average plasma volume for male and female patients is 2950ml SD=590 ml. To detect a 10% increase in plasma volume from hemodilution with a power 0.80 and alpha error 0.05, a one tailed normal distribution t-test determines a sample size fifty. To account for a 10% data loss (technical difficulty, patient withdraw) a sample size of fifty-five would be required.
Fifty-five consecutive adult patients (18 years or older) having burn surgery will be enrolled. Patients with recognized coagulopathy will be excluded. The outcome variables included blood volume (BV, ml), plasma volume (PV, ml) and red blood cell volume (RBCV, ml). All three outcome variables will be measured at two time points; pre-surgery and post-surgery. The pre-surgery measurement will be collected precisely after induction of general anesthesia but prior to surgery start. The post-surgery measurement will be taken immediately after the operation and after all intraoperative red blood cell transfusions are complete. For those patients receiving blood transfusions in the operating room prior to all data collection points, the transfused RBC volume will be recorded and subtracted from the RBCV measured after the transfusion. Transfused RBCV will take into account Hct of 60% for pRBCs. Additional baseline information, including age (year), sex (male, female), weight (kg), and surgery type, will be collected. For the tracer dilution method, the following blood samples will be collected: a baseline (no radiation sample), a first sample 12 minutes after injection (after complete mixing in the blood volume) and additional samples every 6 minutes for at least three successive timed sample points. These multiple timed sample points produce a logarithmic curve of radiation over time, as only a small fraction of albumin leaves the blood volume into the interstitial space. The investigators will compare the pre-operative and post-operative blood volume, RBC volume, and plasma volume measurements to determine if the decrease in hematocrit associated with burn surgery is truly due to hemodilution or loss of RBC volume.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative cohort | – | Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100This cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 prior to any surgical intervention |
| Post-operative cohort | – | Procedure: Burn surgery, Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100This cohort will consist of the same study participants in the pre-operative cohort. The only difference is that this cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 AFTER burn surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-70 year old male or non-pregnant females who have sustained deep partial thickness to full thickness thermal burns between 10-50% TBSA who are undergoing burn surgery
Key inclusion criteria (6 listed)
- Sustained thermal burn of a depth that is deep partial thickness to full thickness and requires operative management
- Burn excision must occur within one week of thermal injury
- Burn size between 10-50% of total body surface area
- Must survive initial resuscitation
- Must consent for blood product transfusion
Key exclusion criteria (3 listed)
- Cause of burn other than thermal injury (ie electrical or chemical injury)
- Women who are nursing, pregnant, or think they may be pregnant
- Patients with recognized coagulopathy
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 |
|---|---|---|
| Burn surgeryBurn surgery including wound debridement, skin grafting | Procedure or surgery | Post-operative cohort |
| Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100 | Diagnostic test | Post-operative cohort, Pre-operative cohort |
Primary outcome
Change in measured plasma volume
Time frame: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Measured plasma volume using Daxor BVA-100
Change in measured RBC volume
Time frame: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Measured RBC volume using Daxor BVA-100
Change in measured total blood volume
Time frame: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete
Measured total blood volume using Daxor BVA-100
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 15 Oct 2024.
- Background: PubMed 16414197Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. doi: 10.1016/j.burns.2005.09.005. Epub 2006 Jan 18.
- Background: PubMed 8471147Budny PG, Regan PJ, Roberts AH. The estimation of blood loss during burns surgery. Burns. 1993 Apr;19(2):134-7. doi: 10.1016/0305-4179(93)90036-8.
- Background: PubMed 11220251Meiser A, Casagranda O, Skipka G, Laubenthal H. [Quantification of blood loss. How precise is visual estimation and what does its accuracy depend on?]. Anaesthesist. 2001 Jan;50(1):13-20. doi: 10.1007/s001010050957. German.
- Background: PubMed 15415456CRISPELL KR, PORTER B, NIESET RT. Studies of plasma volume using human serum albumin tagged with radioactive iodine. J Clin Invest. 1950 May;29(5):513-6. doi: 10.1172/JCI102288. No abstract available.
- Background: PubMed 17496003Manzone TA, Dam HQ, Soltis D, Sagar VV. Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study. J Nucl Med Technol. 2007 Jun;35(2):55-63; quiz 77, 79. doi: 10.2967/jnmt.106.035972. Epub 2007 May 11.
- I-131 albumin Volumex Package InsertLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers outside of the investigators listed in this study group.
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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.
Mark Nelson, MD principal investigator
VCU Medical Center
Michael Feldman, MD principal investigator
VCU Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Blood Loss and Burns, run by Virginia Commonwealth University.
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 6 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: withdrawn, as of the sponsor's last update on 15 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 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?
Change in measured plasma volume (time frame: Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340116, which also lists 5 linked publications.
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 15 Oct 2024.