Study Summary
This trial will study whether Acute normovolemic hemodilution (ANH), a blood conservation technique, can reduce transfusion in complex cardiac surgery patients. ANH has been demonstrated to reduce transfusion in lower risk cardiac surgery without any significant complications.
Eligible Conditions
- Cardiac Surgery
- Acute Kidney Injury
- Congenital Heart Disease
- Aortic Surgery
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 44 Secondary · Reporting Duration: During intraoperative period
24 Hours
24 Hour Chest Tube Output
24 hours
24 Hour Activated Partial Thromboplastin time (aPTT)
24 Hour Fibrinogen
24 Hour Hematocrit (Hct)
24 Hour Hemoglobin (Hgb)
24 Hour International Normalized Ratio (INR)
24 Hour Platelet Count
24 Hour Prothrombin time (PT)
Maximum 24 Hour Vasoactive-Inotropic Score
48 Hours
48 Hour Chest Tube Output
48 hours
48 Hour Activated Partial Thromboplastin time (aPTT)
48 Hour Fibrinogen
48 Hour Hematocrit (Hct)
48 Hour Hemoglobin (Hgb)
48 Hour International Normalized Ratio (INR)
48 Hour Platelet Count
48 Hour Prothrombin time (PT)
Maximum 48 Hour Vasoactive-Inotropic Score
72 Hours
72 Hour Chest Tube Output
72 hours
72 Hour Activated Partial Thromboplastin time (aPTT)
72 Hour Fibrinogen
72 Hour Hematocrit (Hct)
72 Hour Hemoglobin (Hgb)
72 Hour International Normalized Ratio (INR)
72 Hour Platelet Count
72 Hour Prothrombin time (PT)
Acute Kidney Injury (AKI)
Change in mixed venous oxygen saturation as a marker of perfusion
Cryoprecipitate (cryo)
Fresh frozen plasma (FFP)
Maximum 72 Hour Vasoactive-Inotropic Score
Packed red blood cells (pRBC)
Perfusion markers (lactate)
Platelets (PLT)
Hour 72
Number of patients with infection/sepsis
Day 10
Mortality
Conclusion of intraoperative procedure
Maximum Intraoperative Vasoactive-Inotropic Score
During intraoperative period
Rotational Thromboelastometry EXTEM Clotting Time (EXTEM A20)
Rotational Thromboelastometry EXTEM Clotting Time (EXTEM CT)
Rotational Thromboelastometry FIBTEM Maximum Clot Firmness (FIBTEM MCF)
Rotational Thromboelastometry HEPTEM Clotting Time (HEPTEM CT)
Rotational Thromboelastometry HEPTEM/EXTEM Maximum Clot Firmness (HEPTEM/EXTEM MCF)
In the OR during surgery.
Cerebral oximetry using near infrared spectroscopy derived tissue oxygenation as a marker of perfusion
In the operating room (OR) during surgery.
Post-cardiopulmonary bypass HEPTEM/EXTEM MCF
Hour 72
Delirium
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Control Group
1 of 2
Intervention Group
1 of 2
Active Control
Experimental Treatment
112 Total Participants · 2 Treatment Groups
Primary Treatment: Acute normovolemic hemodilution (ANH) · No Placebo Group · Phase 3
Intervention Group
Biological
Experimental Group · 1 Intervention: Acute normovolemic hemodilution (ANH) · Intervention Types: BiologicalControl GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acute normovolemic hemodilution (ANH)
2016
N/A
~160
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during intraoperative period
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,412 Previous Clinical Trials
6,762,385 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
50,078 Patients Enrolled for Acute Kidney Injury
Lorraine Lubin, MDPrincipal InvestigatorUniversity of California, Los Angeles
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Barile, Luigi, Evgeny Fominskiy, Nora Di Tomasso, Ligia Elena Alpìzar Castro, Giovanni Landoni, Monica De Luca, Elena Bignami, Alessandra Sala, Alberto Zangrillo, and Fabrizio Monaco. 2017. “Acute Normovolemic Hemodilution Reduces Allogeneic Red Blood Cell Transfusion in Cardiac Surgery”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000001609.
- Zhou, Zhen-feng, Xiu-ping Jia, Kai Sun, Feng-jiang Zhang, Li-na Yu, Tian Xing, and Min Yan. 2017. “Mild Volume Acute Normovolemic Hemodilution Is Associated with Lower Intraoperative Transfusion and Postoperative Pulmonary Infection in Patients Undergoing Cardiac Surgery -- a Retrospective, Propensity Matching Study”. BMC Anesthesiology. Springer Science and Business Media LLC. doi:10.1186/s12871-017-0305-7.
- Barile L, Fominskiy E, Di Tomasso N, Alpizar Castro LE, Landoni G, De Luca M, Bignami E, Sala A, Zangrillo A, Monaco F. Acute Normovolemic Hemodilution Reduces Allogeneic Red Blood Cell Transfusion in Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Trials. Anesth Analg. 2017 Mar;124(3):743-752. doi: 10.1213/ANE.0000000000001609.
- Lorraine N. Lubin, MD 2022. "Acute Normovolemic Hemodilution in Complex Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049590.
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