Proving Hemodilution in a Human Model for Class I Hemorrhage

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318355
• Other study ID #: 08-08-19E
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodilution
• Hemorrhage
• Shock
• Wounds and Injuries

Intervention

Other:
• normal saline
Crystalloid intravenous solution
• lactated ringers
Crystalloid intravenous solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Community Blood Center of the Carolinas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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