Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06399536 |
| Other study ID # |
WCH20240429 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
West China Hospital |
| Contact |
Ren Liao, M.D. |
| Phone |
+86-18980602177 |
| Email |
liaoren7733[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this trial, we proposed an individualized acute normovolemic hemodilution (ANH), and
conduct a randomized controlled trial to testify the effect of individualized ANH on red
cells requirement for non-cardiac surgeries with anticipating major blood loss in adults.
Description:
Allogeneic blood transfusion (ABT) is often given for patients undergoing major surgery with
large amount of blood loss. However, ABT itself is associated with various complications,
such as anaphylaxis, transfusion related bacterial and viral infections, and transfusion
related lung injury [1-3]. Strategies for reduction of requirements for ABT during surgery
continue to be of an importance in clinical practice.
The current strategies for ABT reduction during major surgery can be divided into the
decrease of operative blood loss and the provision of autologous red cells. Collection of
autologous red cells could be performed several weeks before admission (preoperative
autologous donation, PAD), after anesthetic induction and prior to the surgical incision
(acute normovolemic hemodilution, ANH), or during the operation (cell saver) [4]. ANH is a
technique that remove the whole blood and infuse the colloids or crystalloids at the same
time to get the hemodilution with the normal volume [5]. With the hemodilution, the amounts
of red cells lost with bleeding could be reduced during surgery, and blood viscosity could be
decreased beneficial for improved blood flow and increased venous return at a relative
constant atrial pressure [6]. However, ANH has not been a widely accepted technique despite
these advantages. One possible reason could be the mixed results about application of ANH in
the literature. It was reported to decrease the risk of ABT when compared with the control
group in a meta-analysis including 29 randomized controlled trials [7], but other authors
reported ANH could only decrease intraoperative ABT with no differences in overall
perioperative transfusion requirements [8]. Another reason could be due to the staffing
shortage in clinical practice, especially in China. The implementation of AHN in the
operating room requires the cooperation of a staff team including anesthesiologists,
circulating nurses, and technicians from department of blood transfusion to collect the
autologous blood and store it in refrigerators, and reinfuse the autologous blood under the
supervision and double verification. In addition, what degree of the hemodilution should be
achieved for a patient is lack of evidence and guidance, and the hemodilution can't be
individualized executed.
In our previous study, we proposed the West-China-Liu's Score (Table.1) for individualized
transfusion of red cells and conducted a multi-centered RCT to verify that the application of
this individualized transfusion strategy can decrease the requirement of perioperative red
cells transfusion when compared with the restrictive or liberal strategies without increase
of complications in elective noncardiac surgeries [9]. According to the score, we can
determine the tolerable lower level of hemoglobin (Hb), and it's safe for a patient to keep
his Hb level above the score. With the West-China-Liu's Score, we dilute the patient's Hb
level to the degree of the score plus 2, we can calculate the volume of the collected
autologous blood. For example, a patient's initial Hb level is 12g/dL, the West-China-Liu's
Score is 6, we dilute the Hb level to the score of 6+2=8, and the hemodilution level for him
is Hb of 8g/dL. A 1g/dL Hb level is about 400ml of blood, and the decrease of Hb level from
12g/dL to 8g/dL is about 1600ml of blood. While we infuse the patient with fluids and collect
blood at the same time, we will collect 800ml of the autologous blood for this patient. The
collected autologous blood will be transfused to the patient when his Hb level is decreased
to 6g/dL, or at the end of the operation. By this mean, ANH could be individualized.
Based on previous findings and the theory of individualized transfusion strategy, we
hypothesize that individualized ANH under guidance of West-China Liu's Score can reduce the
requirement of allogeneic red cells.
