Proving Hemodilution in a Human Model for Class I Hemorrhage
Primary Purpose
Hemodilution, Hemorrhage, Shock
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
normal saline
lactated ringers
Sponsored by
About this trial
This is an interventional treatment trial for Hemodilution focused on measuring hemodilution, hemorrhage, trauma, lactate, base deficit, randomized control trial
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Lactated Ringers
Normal Saline
Arm Description
Control group that receives no intravenous fluid after blood donation
Experimental group that receives two liters lactated ringers after blood donation.
Experimental group that receives two liters normal saline after blood donation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02318355
First Posted
December 10, 2014
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Community Blood Center of the Carolinas
1. Study Identification
Unique Protocol Identification Number
NCT02318355
Brief Title
Proving Hemodilution in a Human Model for Class I Hemorrhage
Official Title
Resuscitative Effect of Two Liters of Crystalloid on Hemodilution and Base Deficit in Healthy Volunteer Blood Donors With Class I Hemorrhage.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Community Blood Center of the Carolinas
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodilution, Hemorrhage, Shock, Wounds and Injuries
Keywords
hemodilution, hemorrhage, trauma, lactate, base deficit, randomized control trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group that receives no intravenous fluid after blood donation
Arm Title
Lactated Ringers
Arm Type
Experimental
Arm Description
Experimental group that receives two liters lactated ringers after blood donation.
Arm Title
Normal Saline
Arm Type
Experimental
Arm Description
Experimental group that receives two liters normal saline after blood donation.
Intervention Type
Other
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
Crystalloid intravenous solution
Intervention Type
Other
Intervention Name(s)
lactated ringers
Other Intervention Name(s)
LR
Intervention Description
Crystalloid intravenous solution
Primary Outcome Measure Information:
Title
Hemoglobin (g/dL)
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Lactate (mmol/L)
Description
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.
Time Frame
2 hours
Title
Base deficit (mmol/L)
Description
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.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald F Sing, DO
Organizational Affiliation
Professor of Surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29879520
Citation
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.
Results Reference
derived
PubMed Identifier
26496098
Citation
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.
Results Reference
derived
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Proving Hemodilution in a Human Model for Class I Hemorrhage
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