Proving Hemodilution in a Human Model for Class I Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Shock; Hemorrhage; Hemodilution
• Intervention / Treatment: Other: lactated ringers; Other: normal saline

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 Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Community Blood Center of the Carolinas
• Investigators: Principal Investigator: Ronald F Sing, DO, Professor of Surgery

Publications and helpful links

General 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.
• Ross 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: trauma; hemorrhage; randomized control trial; lactate; hemodilution; base deficit
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage
• Other Study ID Numbers: 08-08-19E