Hemodilution, Hemorrhage, Shock, Wounds and Injuries
Conditions
Keywords
hemodilution, hemorrhage, trauma, lactate, base deficit, randomized control trial
Brief 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.
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.
Interventions
OTHERnormal saline
Crystalloid intravenous solution
OTHERlactated ringers
Crystalloid intravenous solution
Sponsors
Community Blood Center of the Carolinas
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* blood bank inclusion criteria for donation * able to donate 500cc blood * age \> or = 18
Exclusion criteria
* unable to obtain IV access * multiple blood draws fail to run on laboratory assays
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin (g/dL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lactate (mmol/L) | 2 hours | 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. |
| Base deficit (mmol/L) | 2 hours | 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. |
Outcome results
None listed