Proving Hemodilution in a Human Model for Class I Hemorrhage
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About
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.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
165 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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