HemodilutionNCT02318355
Proving Hemodilution in a Human Model for Class I Hemorrhage
A study testing normal saline and lactated ringers in people with Hemodilution and Hemorrhage, run by Wake Forest University Health Sciences.
Trial summary
This study is a randomized control trial in volunteer blood donors to quantify the effect of blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation such as base deficit and lactate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodilution, Hemorrhage, Shock
- What is being tested?
- normal saline and lactated ringers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- blood bank inclusion criteria for donation
- able to donate 500cc blood
- age > or = 18
Who cannot join
- unable to obtain IV access
- multiple blood draws fail to run on laboratory assays
About this study
Official title: Resuscitative Effect of Two Liters of Crystalloid on Hemodilution and Base Deficit in Healthy Volunteer Blood Donors With Class I Hemorrhage.
This study is a randomized control trial in volunteer blood donors to quantify the effect of blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation such as base deficit and lactate.
Read the detailed description
Blood donors were randomized to one of three arms after donation of 500cc of blood. The control group received no intravenous fluids, while donors in the two intervention arms wither received two liters normal saline or lactated ringers. Chemistries and blood gases were obtained before donation, after donation and after resuscitation. Donors hemoglobin levels were then compared over time and between study arms. Additionally, lactate and base deficit, which are markers of shock, will be collected at the time points as well to measure their response to resuscitation. Standard statistical tests were used to compare the laboratory values between groups.
- Conditions
- Hemodilution, Hemorrhage, Shock, Wounds and Injuries
- Being tested
- normal saline, lactated ringers
- Keywords
- hemodilution, hemorrhage, trauma, lactate, base deficit, randomized control trial
- Medical subject headings
- Hemorrhage, Shock, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
Also called NS
Crystalloid intravenous solution
lactated ringersOther
Also called LR
Crystalloid intravenous solution
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group that receives no intravenous fluid after blood donation |
| Lactated Ringers | Experimental | Experimental group that receives two liters lactated ringers after blood donation. Receives: Other: lactated ringers |
| Normal Saline | Experimental | Experimental group that receives two liters normal saline after blood donation. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (g/dL)
obtain hemoglobin immediately before and after donation, and after resuscitation with intravenous fluids. From donation to end of resuscitation, the time frame will be 2 hours or less. Donors will not be followed after the third blood draw and will be discharged from the study. No follow-up was obtained.
Measured: 2 hours
Secondary outcomes (2)
Lactate (mmol/L)
Obtain lactate immediately before and after donation, and after resuscitation with intravenous fluids. Lactate is a measure of aneorbic metabolism and increases with worsening shock and hypoperfusion as seen in hemorrhage. From donation to end of resuscitation, the time frame will be 2 hours or less. Donors will not be followed after the third blood draw and will be discharged from the study. No follow-up was obtained.
Measured: 2 hours
Base deficit (mmol/L)
Obtain base deficit immediately before and after donation, and after resuscitation with intravenous fluids. Base deficit is a measure of unmeasured acid in the blood, indicating acidosis and shock, and increases in worsening hypoperfusion. From donation to end of resuscitation, the time frame will be 2 hours or less. Donors will not be followed after the third blood draw and will be discharged from the study. No follow-up was obtained.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodilutionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Community Blood Center of the Carolinas
- Responsible party
- Sponsor
- Investigators
- Ronald F Sing, DO, Principal investigator, Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318355
- Sponsor's protocol ID
- 08-08-19E
- Status last verified
- Dec 2014
- First submitted
- 10 Dec 2014
- Last updated
- 21 Apr 2022
- Results posted
- No
Publications
Ross SW, Christmas AB, Fischer PE, Holway H, Seymour R, Huntington CR, Heniford BT, Sing RF. Defining Dogma: Quantifying Crystalloid Hemodilution in a Prospective Randomized Control Trial with Blood Donation as a Model for Hemorrhage. J Am Coll Surg. 2018 Sep;227(3):321-331. doi: 10.1016/j.jamcollsurg.2018.05.005. Epub 2018 Jun 4.
PubMed 29879520Ross SW, Christmas AB, Fischer PE, Holway H, Walters AL, Seymour R, Gibbs MA, Heniford BT, Sing RF. Impact of common crystalloid solutions on resuscitation markers following Class I hemorrhage: A randomized control trial. J Trauma Acute Care Surg. 2015 Nov;79(5):732-40. doi: 10.1097/TA.0000000000000833.
PubMed 26496098
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitative Effect of Two Liters of Crystalloid on Hemodilution and Base Deficit in Healthy Volunteer Blood Donors With Class I Hemorrhage.
- ClinicalTrials.gov ID
- NCT02318355
- Acronym / sponsor ID
- 08-08-19E
- Conditions
- Hemodilution, Hemorrhage, Shock, Wounds and Injuries
- Keywords
- hemodilution, hemorrhage, trauma, lactate, base deficit, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Community Blood Center of the Carolinas
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Dec 2014 (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.
This study is a randomized control trial in volunteer blood donors to quantify the effect of blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation such as base deficit and lactate.
Detailed description
Blood donors were randomized to one of three arms after donation of 500cc of blood. The control group received no intravenous fluids, while donors in the two intervention arms wither received two liters normal saline or lactated ringers. Chemistries and blood gases were obtained before donation, after donation and after resuscitation. Donors hemoglobin levels were then compared over time and between study arms. Additionally, lactate and base deficit, which are markers of shock, will be collected at the time points as well to measure their response to resuscitation. Standard statistical tests were used to compare the laboratory values between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group that receives no intravenous fluid after blood donation |
| Lactated Ringers | Experimental | Other: lactated ringersExperimental group that receives two liters lactated ringers after blood donation. |
| Normal Saline | Experimental | Other: normal salineExperimental group that receives two liters normal saline after blood donation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- blood bank inclusion criteria for donation
- able to donate 500cc blood
- age > or = 18
Key exclusion criteria (2 listed)
- unable to obtain IV access
- multiple blood draws fail to run on laboratory assays
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 |
|---|---|---|
| normal salineAlso: NSCrystalloid intravenous solution | Other | Normal Saline |
| lactated ringersAlso: LRCrystalloid intravenous solution | Other | Lactated Ringers |
Primary outcome
Hemoglobin (g/dL)
Time frame: 2 hours
obtain hemoglobin immediately before and after donation, and after resuscitation with intravenous fluids. From donation to end of resuscitation, the time frame will be 2 hours or less. Donors will not be followed after the third blood draw and will be discharged from the study. No follow-up was obtained.
2 secondary outcomes
Lactate (mmol/L)
Time frame: 2 hours
Base deficit (mmol/L)
Time frame: 2 hours
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 21 Apr 2022.
- Derived from this study: PubMed 29879520Ross SW, Christmas AB, Fischer PE, Holway H, Seymour R, Huntington CR, Heniford BT, Sing RF. Defining Dogma: Quantifying Crystalloid Hemodilution in a Prospective Randomized Control Trial with Blood Donation as a Model for Hemorrhage. J Am Coll Surg. 2018 Sep;227(3):321-331. doi: 10.1016/j.jamcollsurg.2018.05.005. Epub 2018 Jun 4.
- Derived from this study: PubMed 26496098Ross SW, Christmas AB, Fischer PE, Holway H, Walters AL, Seymour R, Gibbs MA, Heniford BT, Sing RF. Impact of common crystalloid solutions on resuscitation markers following Class I hemorrhage: A randomized control trial. J Trauma Acute Care Surg. 2015 Nov;79(5):732-40. doi: 10.1097/TA.0000000000000833.
Related trials for Hemodilution
Not yet recruiting
Acute Normovolemic Hemodilution in Bone Cancer Surgery
Acute Normovolemic Hemodilution
Recruiting
The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Acute Normovolemic Hemodilution, Bone Tumor
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
RecruitingObservational study
Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
Acute Kidney Injury
Not yet recruitingPhase 3
Normal Saline Infusion After Intravenous Thrombolysis in Stroke
Brain Infarction
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.
Ronald F Sing, DO principal investigator
Professor of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing normal saline and lactated ringers in people with Hemodilution and Hemorrhage, run by Wake Forest University Health Sciences.
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 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 21 Apr 2022. 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?
Hemoglobin (g/dL) (time frame: 2 hours). 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 NCT02318355, which also lists 2 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 21 Apr 2022.