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.
1 other identifier
interventional
165
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedApril 21, 2022
December 1, 2014
7 months
December 10, 2014
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Lactate (mmol/L)
2 hours
Base deficit (mmol/L)
2 hours
Study Arms (3)
Control
NO INTERVENTIONControl group that receives no intravenous fluid after blood donation
Lactated Ringers
EXPERIMENTALExperimental group that receives two liters lactated ringers after blood donation.
Normal Saline
EXPERIMENTALExperimental group that receives two liters normal saline after blood donation.
Interventions
Eligibility Criteria
You may qualify if:
- able to donate 500cc blood
- age \> or = 18
You may not qualify if:
- unable to obtain IV access
- multiple blood draws fail to run on laboratory assays
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 29879520DERIVEDRoss 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.
PMID: 26496098DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald F Sing, DO
Professor of Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 17, 2014
Study Start
November 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 21, 2022
Record last verified: 2014-12