Blood Volume AnalysisNCT02148809
Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
A study testing 1mL of I-131 Human Serum Albumin is injected prior to the measurements in people with Blood Volume Analysis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Blood Volume Analysis
- What is being tested?
- 1mL of I-131 Human Serum Albumin is injected prior to the measurements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non- inflammatory degenerative joint disease of the hip
- Patients scheduled for unilateral primary total hip arthroplasty
- Age between 50 and 75 years
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery
Who cannot join
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods
- Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
- Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
Show all 14Show fewer
- Congestive Heart Failure (at least one medication to treat congestive heart failure)
- Coronary artery disease (s/p bypass, stent or AMI)
- Kidney insufficiency (creatinine > 1.5)
- Aortic or mitral valve disease
- Pulmonary hypertension
- Revision Hip Surgery
- Inadequate intravenous fluid substitution within the first 6 hrs (<3 liters)
- Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
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
Read the detailed description
Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.
- Conditions
- Blood Volume Analysis
- Being tested
- 1mL of I-131 Human Serum Albumin is injected prior to the measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1mL of I-131 Human Serum Albumin is injected prior to the measurementsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Blood Volume Analysis, Fluid | Experimental | 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 Receives: Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Blood Volume
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.
Measured: preoperatively and 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood Volume AnalysisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148809
- Sponsor's protocol ID
- IRB # 13193
- Status last verified
- May 2017
- First submitted
- 23 May 2014
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Niemi TT, Pitkanen M, Syrjala M, Rosenberg PH. Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty. Acta Anaesthesiol Scand. 2000 Apr;44(4):457-64. doi: 10.1034/j.1399-6576.2000.440418.x.
PubMed 10757582Hahn RG. Haemoglobin dilution from epidural-induced hypotension with and without fluid loading. Acta Anaesthesiol Scand. 1992 Apr;36(3):241-4. doi: 10.1111/j.1399-6576.1992.tb03457.x.
PubMed 1574972Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
PubMed 14739801Drobin D, Hahn RG. Time course of increased haemodilution in hypotension induced by extradural anaesthesia. Br J Anaesth. 1996 Aug;77(2):223-6. doi: 10.1093/bja/77.2.223.
PubMed 8881630Manzone 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.
PubMed 17496003
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
- ClinicalTrials.gov ID
- NCT02148809
- Acronym / sponsor ID
- IRB # 13193
- Conditions
- Blood Volume Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Volume Analysis, Fluid | Experimental | Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurementsPreop 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non- inflammatory degenerative joint disease of the hip
- Patients scheduled for unilateral primary total hip arthroplasty
- Age between 50 and 75 years
- Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
- Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery
Key exclusion criteria (14 listed)
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods
- Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
- Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
- Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1mL of I-131 Human Serum Albumin is injected prior to the measurements | Radiation | Blood Volume Analysis, Fluid |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10757582Niemi TT, Pitkanen M, Syrjala M, Rosenberg PH. Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty. Acta Anaesthesiol Scand. 2000 Apr;44(4):457-64. doi: 10.1034/j.1399-6576.2000.440418.x.
- Background: PubMed 1574972Hahn RG. Haemoglobin dilution from epidural-induced hypotension with and without fluid loading. Acta Anaesthesiol Scand. 1992 Apr;36(3):241-4. doi: 10.1111/j.1399-6576.1992.tb03457.x.
- Background: PubMed 14739801Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
- Background: PubMed 8881630Drobin D, Hahn RG. Time course of increased haemodilution in hypotension induced by extradural anaesthesia. Br J Anaesth. 1996 Aug;77(2):223-6. doi: 10.1093/bja/77.2.223.
- Background: PubMed 17496003Manzone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1mL of I-131 Human Serum Albumin is injected prior to the measurements in people with Blood Volume Analysis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Blood Volume (time frame: preoperatively and 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148809, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.