Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127825
Other study ID # ANES-2017-25808
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date April 30, 2021

Study information

Verified date March 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this small randomized pilot study is to evaluate adherence to strict transfusion protocols in both the control and ANH group examining compliant and noncompliant transfusion rates and reasons for violation of the protocol if present. Data on transfusion requirements for both groups (with and without ANH) will be evaluated to determine sample size and feasibility of performing a larger study on ANH in our patient population. The ultimate purpose of a larger study would be to determine if acute normovolemic hemodilution results in a reduction in red blood cell units transfused in patients undergoing cardiac surgery involving cardiopulmonary bypass (CPB) and to carefully determine provider adherence to specific transfusion triggers for the administration of each unit of harvested and banked blood transfused. Secondary endpoints that will be evaluated in a larger study include any difference in the number of other blood products transfused including fresh frozen plasma, platelets, and cryoprecipitate as well as differences in coagulation status as measured by thromboelastography (TEG), INR/PTT, platelet count, and fibrinogen level, and ICU/hospital length of stay.


Description:

Cardiac surgery patients are typically at higher risk of receiving blood transfusions during surgery than patients presenting for most other surgical procedures. Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves removing blood from appropriate patients immediately after the induction of anesthesia, replacing the volume lost with colloids (e.g. 5% albumin), then storing and returning this blood to the patient at the completion of the surgical procedures. By reducing the patient's hematocrit during surgery, the blood that is shed during the procedure has a lower red blood cell volume and therefore fewer red blood cells are lost during major blood loss. In addition, the autologous stored blood contains coagulation factors that are spared and returned following the procedure. This process is already performed here and at other institutions as a potential means of reducing transfusions in high risk patients. However, in spite of multiple publications, the actual value of this procedure is unclear, in part because many of the published studies in cardiac surgical patients failed to establish firm protocol- specific guidelines for either returning harvested blood to the patient or for using banked blood, or because it is unclear whether these guidelines were actually followed during surgery (rather than left to the discretion of anesthesiologists and surgeons). The primary goal of this pilot study is to implement rigorous transfusion protocols for both ANH and routine transfusion practice and to examine compliant and noncompliant transfusion rates in both the ANH and control groups, evaluating reasons for violation of the transfusion protocol if applicable and to determine the feasibility of performing a larger study on ANH. Secondary goals for this pilot study include gathering data on transfusion rates in ANH versus control patients to determine the sample size for a larger, definitive study in which the primary goal would be to evaluate the effectiveness of ANH in reducing transfusion of banked blood units during cardiac surgery as compared to control patients in which ANH is not used. Secondary endpoints of a larger study would also include evaluating coagulation status in patients undergoing ANH versus control patients.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing cardiac surgery involving one of the following procedures at the University of Minnesota: A) combined coronary artery bypass graft and valve repair/replacement B) redo cardiac surgery C) left ventricular assist device placement Exclusion Criteria: - Hemoglobin concentration < 12 g/dl - Patients undergoing cardiac surgery without the use of cardiopulmonary bypass

Study Design


Intervention

Procedure:
Acute Normovolemic Hemodilution (ANH)
Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves removing blood from appropriate patients immediately after the induction of anesthesia, replacing the volume lost with colloids (e.g. 5% albumin), then storing and returning this blood to the patient at the completion of the surgical procedures.

Locations

Country Name City State
United States University of Minnesota Medical Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total blood products transfused intraoperatively The total volume (reported in ml) of blood products transfused intraoperatively. A lower volume of transfused blood products indicates greater efficacy of the intervention. duration of surgery (approximately 12 hours)
See also
  Status Clinical Trial Phase
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT03930784 - A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Recruiting NCT04887415 - Respiratory Strength Training in Cardiac Surgical Patients N/A
Recruiting NCT05254262 - Multicenter National Trial of Clinical Results of Surgical Elderly Patients
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT05155878 - Prognostic Factors in Periampullary Tumors and Cysts
Recruiting NCT04967391 - Tumescence in HNC Skin Graft Reconstruction Phase 3
Terminated NCT03757455 - ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy N/A
Completed NCT03793816 - Tonsillectomy Using BiZactâ„¢ - a Randomized Side-controlled Clinical Trial N/A
Completed NCT03246165 - Predictive Factors and Complications of Delirium
Withdrawn NCT04090918 - Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery
Completed NCT05373238 - Same Day Discharge After Laparoscopic Hysterectomy
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Not yet recruiting NCT05046925 - PACU for Postoperative Care After Major Thoracic and Abdominal Surgery
Completed NCT04550156 - Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections N/A
Not yet recruiting NCT04199208 - Does Prehabilitation Improve Outcome in Coloncancer Surgery? N/A
Completed NCT04257344 - Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery
Active, not recruiting NCT03721471 - Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty