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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
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 10, 2014
    Last Updated
    April 19, 2022
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    Community Blood Center of the Carolinas
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    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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