Measurement of Blood Volume Loss During Burn Surgery

NCT03340116 | Withdrawn FDA Device

• 2 other identifiers: HM20015231HM20011159
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Burn surgery is associated with significant reductions in hematocrit. However, it is unclear whether these reductions are the result of hemodilution from non-red cell containing intraoperative transfusions or from loss of red blood cells. The investigators will be using the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total blood volume, plasma volume, and RBC volume using the indicator dilution technique. By comparing pre-operative measurements of blood volume, plasma volume, and RBC volume to that of post-operative measurements after burn surgery, the investigators can determine the primary cause of the reduction in hematocrit associated with burn surgery. The investigators hypothesize that these reductions in hematocrit are primarily the result of hemodilution rather than blood loss and that there will be a statistically significant difference in measured plasma volume from the pre-operative group to the post-operative group.

Conditions

Surgical Blood Loss; Burns

Outcome Measures

Primary Outcomes (3)

• Change in measured plasma volume

  Measured plasma volume using Daxor BVA-100

  Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete

• Change in measured RBC volume

  Measured RBC volume using Daxor BVA-100

  Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete

• Change in measured total blood volume

  Measured total blood volume using Daxor BVA-100

  Pre-operative period after intubation, but before surgery start and post-operative period after surgery stop and after all intraoperative blood transfusions are complete

Study Arms (2)

Pre-operative cohort

This cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 prior to any surgical intervention

Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100

Post-operative cohort

This cohort will consist of the same study participants in the pre-operative cohort. The only difference is that this cohort will have their total blood volume, RBC volume, and plasma volumes measured using the Daxor BVA-100 AFTER burn surgery.

Procedure: Burn surgery; Diagnostic Test: Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100

Interventions

Burn surgery PROCEDURE

Burn surgery including wound debridement, skin grafting

Post-operative cohort

Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100 DIAGNOSTIC_TEST

Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100

Post-operative cohort; Pre-operative cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18-70 year old male or non-pregnant females who have sustained deep partial thickness to full thickness thermal burns between 10-50% TBSA who are undergoing burn surgery

You may qualify if:

• Sustained thermal burn of a depth that is deep partial thickness to full thickness and requires operative management
• Burn excision must occur within one week of thermal injury
• Burn size between 10-50% of total body surface area
• Must survive initial resuscitation
• Must consent for blood product transfusion
• Male or non-pregnant female

You may not qualify if:

• Cause of burn other than thermal injury (ie electrical or chemical injury)
• Women who are nursing, pregnant, or think they may be pregnant
• Patients with recognized coagulopathy

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Daxor Corporation: collaborator

Related Publications (5)

• Ong YS, Samuel M, Song C. Meta-analysis of early excision of burns. Burns. 2006 Mar;32(2):145-50. doi: 10.1016/j.burns.2005.09.005. Epub 2006 Jan 18.

  PMID: 16414197 BACKGROUND

• Budny PG, Regan PJ, Roberts AH. The estimation of blood loss during burns surgery. Burns. 1993 Apr;19(2):134-7. doi: 10.1016/0305-4179(93)90036-8.

  PMID: 8471147 BACKGROUND

• Meiser A, Casagranda O, Skipka G, Laubenthal H. [Quantification of blood loss. How precise is visual estimation and what does its accuracy depend on?]. Anaesthesist. 2001 Jan;50(1):13-20. doi: 10.1007/s001010050957. German.

  PMID: 11220251 BACKGROUND

• CRISPELL KR, PORTER B, NIESET RT. Studies of plasma volume using human serum albumin tagged with radioactive iodine. J Clin Invest. 1950 May;29(5):513-6. doi: 10.1172/JCI102288. No abstract available.

  PMID: 15415456 BACKGROUND

• Manzone TA, Dam HQ, Soltis D, Sagar VV. Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study. J Nucl Med Technol. 2007 Jun;35(2):55-63; quiz 77, 79. doi: 10.2967/jnmt.106.035972. Epub 2007 May 11.

  PMID: 17496003 BACKGROUND

Related Links

• I-131 albumin Volumex Package Insert

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples drawn via venipuncture

MeSH Terms

Conditions

Blood Loss, Surgical; Burns

Interventions

Plasma Volume

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Blood Volume; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemodynamics; Cardiovascular Physiological Phenomena

Study Officials

• Mark Nelson, MD

  VCU Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Feldman, MD

  VCU Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 13, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share