Proving Hemodilution in a Human Model for Class I Hemorrhage

Not Applicable

Completed

• Conditions: Wounds and Injuries; Shock; Hemodilution; Hemorrhage
• Interventions: Other: lactated ringers; Other: normal saline

• Registration Number: NCT02318355
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• blood bank inclusion criteria for donation
• able to donate 500cc blood
• age > or = 18

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Exclusion Criteria

• unable to obtain IV access
• multiple blood draws fail to run on laboratory assays

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactated Ringers	lactated ringers	Experimental group that receives two liters lactated ringers after blood donation.
Normal Saline	normal saline	Experimental group that receives two liters normal saline after blood donation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.