Proving Hemodilution in a Human Model for Class I Hemorrhage

NCT ID: NCT02318355

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Hemodilution; Hemorrhage; Shock; Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Control group that receives no intravenous fluid after blood donation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lactated Ringers

Experimental group that receives two liters lactated ringers after blood donation.

Group Type: EXPERIMENTAL

lactated ringers

Intervention Type: OTHER

Crystalloid intravenous solution

Normal Saline

Experimental group that receives two liters normal saline after blood donation.

Group Type: EXPERIMENTAL

normal saline

Intervention Type: OTHER

Crystalloid intravenous solution

Interventions

normal saline

Crystalloid intravenous solution

Intervention Type: OTHER

lactated ringers

Crystalloid intravenous solution

Intervention Type: OTHER

Other Intervention Names

NS; LR

Eligibility Criteria

Inclusion Criteria

• able to donate 500cc blood
• age > or = 18

Exclusion Criteria

• unable to obtain IV access
• multiple blood draws fail to run on laboratory assays

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Community Blood Center of the Carolinas

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald F Sing, DO

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery

References

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.

Reference Type: DERIVED

PMID: 29879520 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26496098 (View on PubMed)

Other Identifiers

08-08-19E

Identifier Type: -

Identifier Source: org_study_id