Proving Hemodilution in a Human Model for Class I Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resuscitative Effect of Two Liters of Crystalloid on Hemodilution and Base Deficit in Healthy Volunteer Blood Donors With Class I Hemorrhage.

Conditions
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Hemodilution, Hemorrhage, Shock, Wounds and Injuries

Intervention / Treatment
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* Other: normal saline
* Other: lactated ringers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group that receives no intravenous fluid after blood donation | |
| Experimental: Lactated Ringers<br>Experimental group that receives two liters lactated ringers after blood donation. | Other: lactated ringers<br>* Crystalloid intravenous solution<br>* Other names: LR;|
| Experimental: Normal Saline<br>Experimental group that receives two liters normal saline after blood donation. | Other: normal saline<br>* Crystalloid intravenous solution<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, hemodilution, hemorrhage, lactate, base deficit, randomized control trial