NCT02318355

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemodilution
• Hemorrhage
• Shock
• Wounds and Injuries

Interventions

Type	Name	Description
OTHER	normal saline	Crystalloid intravenous solution
OTHER	lactated ringers	Crystalloid intravenous solution

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-12-17
• Last updated: 2022-04-21