NCT05539846

Explore the Feasibility of Modified Blood Collection Method

Completed NA Last updated 7 December 2022

What this trial tests

NA trial testing modified blood collection method in Autologous Blood Transfusion in 92 participants. Completed in 30 November 2020.

Timeline

1 February 2019

Primary endpoint
31 October 2020

30 November 2020

Quick facts

Lead sponsor	Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	92
Start date	1 February 2019
Primary completion	31 October 2020
Estimated completion	30 November 2020
Sites	1 location across China

Drugs / interventions tested

• modified blood collection method

Conditions studied

• Autologous Blood Transfusion — all drugs for Autologous Blood Transfusion →

Sponsor

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Who can join

Eligibility, any sex, with Autologous Blood Transfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Blood collection method: routine preparation according to predeposit autologous blood transfusion. Control group: according to the conventional blood collection method, the bevel of the needle head of the blood collection needle was upward, and the needle was inserted at an angle of 30-45 degrees according to the patient's blood vessel. Test group: the bevel of the needle head of the blood collection needle was downward, and the needle was inserted into the skin with the bevel of the needle parallel to the skin. The other blood collection operations of the two groups were the same, the blood collection volume was 400 mL and the routine treatment was performed after the blood collection. Blood collection process was as follows.

1. Check the patient information and prepare for blood collection.
2. Explain the purpose, significance and operation process to the patients, get the understanding of the patients and their families, and sign the informed consent.
3. Close the doors and windows, pull the bed curtain, pay attention to protect the patient's privacy, and the patient should wear a mask.
4. Assist the patient to take the flat lying position, select the middle elbow vein, and strictly disinfect the local skin. In the control group, the wedge-shaped slope of the needle head of the blood collection needle is upward, and the needle is inserted at an angle of 30-45 degrees according to the blood vessel condition of the patient. In the experimental group, the wedge-shaped slope of the needle head of the blood collection needle is downward, and the needle is inserted parallel to the skin. After the puncture is successful, shake the blood bag evenly to prevent hemolysis and blood clot.
5. The nurse shall first establish a venous access (standby) for the patient on the opposite limb of the blood collection, measure the patient's blood pressure and pulse and record it, and give ECG monitoring if necessary. During blood collection, observe the patient's complexion and pulse, and ask if there are symptoms such as palpitation, chest tightness and chest pain. The patient with ECG monitoring shall pay attention to the heart rhythm and heart rate.
6. When the blood collection reaches the predetermined blood volume, pull out the needle and compress the needle eye with a dry cotton ball for 5 \~ 10 minutes. Especially in older patients, bleeding should be prevented due to poor vascular elasticity. The blood bag drainage tube shall be sealed with a hot press sealing machine, and the patient's name, hospitalization number, blood type, blood volume, blood collection date, blood collector and nurse's signature shall be indicated. It shall be sent to the blood bank for storage at 4 ℃, and the effective storage period is 21 days. The patient's blood pressure and pulse were measured again and recorded.
7. The blood was collected 1 \~ 2 weeks before operation, and can be stored for 1 \~ 3 times. Each time the blood collection volume was 10 ml / kg body weight. The interval between the two blood storage was about 3 days. The blood storage was stopped 3 days before operation.
8. Record all indicators. The size of bruises (spots) was measured after 24 hours.

Observation indicators: ① blood spilled from the bevel of the needle when the needle was inserted; ② the diameter of the bruise area was greater than 5 mm after 24 hours; ③ there was a blood clot during the autologous blood transfusion when checked; ④ changes of heart rate and blood pressure before and after blood collection; ⑤ patient pain score (NRS score); ⑥ time required to collect 400 ml of blood; ⑦ adverse reactions, dizziness, palpitations, pale complexion, low volume shock, etc.

Statistical methods: SPSS 25.0 statistical software was used for statistical analysis of the data. The measurement data were subject to normal distribution and expressed by mean ± standard deviation (). Independent sample t-test was used for inter group comparison. Paired sample t-test was used for comparison before and after treatment. The counting data was expressed by rate or constituent ratio (%), and chi square test was used for inter group comparison (χ2), inspection level α=0.05。

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimisation and Effect Analysis of the Blood Collection Method in Pre-Deposit Autotransfusion Patients Undergoing Thoracotomy Surgery.
   Jia L, Wang Y, Zhang W, Lin Y, et al · · 2023 · PMID 37753340 · DOI 10.2147/jmdh.s424470