Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
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|ClinicalTrials.gov Identifier: NCT02148809|
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.
The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.
Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels
|Condition or disease||Intervention/treatment||Phase|
|Blood Volume Analysis||Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||July 2016|
Experimental: Blood Volume Analysis, Fluid
Preop I-131 is given and the BVA is performed, 6 hours after surgery the same procedure will be done to compare the TBV at both points
Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements
- Change in Total Blood Volume [ Time Frame: preoperatively and 6 hours postoperatively ]The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.
- Change IN Plasma Volume PV [ Time Frame: preoperative and 6 hours postoperatively ]
An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq [10-30 mCi]) in saline.
Measurement was performed directly before surgery in the holding area and 6 hours after surgery.
Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148809
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|