Autologous Blood TransfusionNCT05539846
Explore the Feasibility of Modified Blood Collection Method
A study testing modified blood collection method in people with Autologous Blood Transfusion, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autologous Blood Transfusion
- What is being tested?
- modified blood collection method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- weight: ≥50 Kg;
- hemoglobin ≥110 g/L;
- heart function: I-II;
- patients who were expected to have a large amount of surgical bleeding and might require blood transfusion;
- with surgical indications and surgical conditions.
Who cannot join
- having a history of hematophobia;
- having communication difficulties and cannot cooperate;
- having blood collection interruption caused by various accidents.
Trial locations and contacts
1 site in 1 country.
China1 site
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou, Zhejiang, 317000
About this study
Official title: Optimization and Effect Analysis of Blood Collection Method Based on Patient Demand
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.
- Check the patient information and prepare for blood collection.
- Explain the purpose, significance and operation process to the patients, get the understanding of the patients and their families, and sign the informed consent.
- Close the doors and windows, pull the bed curtain, pay attention to protect the patient's privacy, and the patient should wear a mask.
- 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.
- 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.
- 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.
- 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.
- Record all indicators. The size of bruises (spots) was measured after 24 hours.
Read more
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。
- Conditions
- Autologous Blood Transfusion
- Being tested
- modified blood collection method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified blood collection methodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Not described Receives: Procedure: modified blood collection method |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of blood spill
The incidence of blood spill of the control group is 80.9%, while it of the test group is 0.00%.
Measured: when the needle was inserted
incidence of bruise area
The incidence of bruise area of the control group is 63.8%, while it of the test group is 13.3%.
Measured: after 24 hours
incidence of blood clot
The incidence of blood clot of the control group is 10.6%, while it of the test group is 0.00%.
Measured: during the autologous blood transfusion when checked
incidence of dizziness
The incidence of dizziness of the control group is 2.1%, while it of the test group is 2.2%.
Measured: After blood collection
heart rate
Heart rate of the control group before and after blood collection is 77.19±6.20 and 77.94±6.83 respectively. Heart rate of the test group before and after blood collection is 76.11±5.59 and 77.22±4.32 respectively.
Measured: before and after blood collection
blood pressure
Systolic blood pressure of the control group before and after blood collection is 124.85±7.94 and 125.7±6.75 respectively. Systolic blood pressure of the test group before and after blood collection is 124.93±7.04 and 125.76±6.41 respectively. Diastolic blood pressure of the control group before and after blood collection is 77.87±5.79 and 77.43±4.29 respectively. Diastolic blood pressure of the test group before and after blood collection is 77.62±5.08 and 76.6±4.40 respectively.
Measured: before and after blood collection
patient pain score
Patient pain score of the control group is 12.51±0.98. Patient pain score of the test group is 1.53±0.69.
Measured: during blood collection
the time required to collect 400 mL of blood
The time required to collect 400 mL of blood of the control group is 766.62±83.18. The time required to collect 400 mL of blood of the test group is 481.98±69.76.
Measured: during blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Feb 2019
- Primary completion31 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autologous Blood TransfusionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Fu, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539846
- Sponsor's protocol ID
- TZhospital 001
- Status last verified
- Dec 2022
- First submitted
- 7 Sep 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia L, Wang Y, Zhang W, Lin Y, Chen F, Wan Y, Fu X. Optimisation and Effect Analysis of the Blood Collection Method in Pre-Deposit Autotransfusion Patients Undergoing Thoracotomy Surgery. J Multidiscip Healthc. 2023 Sep 20;16:2793-2798. doi: 10.2147/JMDH.S424470. eCollection 2023.
PubMed 37753340
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Effect Analysis of Blood Collection Method Based on Patient Demand
- ClinicalTrials.gov ID
- NCT05539846
- Acronym / sponsor ID
- TZhospital 001
- Conditions
- Autologous Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Check the patient information and prepare for blood collection.
- Explain the purpose, significance and operation process to the patients, get the understanding of the patients and their families, and sign the informed consent.
- Close the doors and windows, pull the bed curtain, pay attention to protect the patient's privacy, and the patient should wear a mask.
- 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.
- 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.
- 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.
- 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.
- 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。
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: modified blood collection method |
| control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- weight: ≥50 Kg;
- hemoglobin ≥110 g/L;
- heart function: I-II;
- patients who were expected to have a large amount of surgical bleeding and might require blood transfusion;
- with surgical indications and surgical conditions.
Key exclusion criteria (3 listed)
- having a history of hematophobia;
- having communication difficulties and cannot cooperate;
- having blood collection interruption caused by various accidents.
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 |
|---|---|---|
| modified blood collection methodThe 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. | Procedure or surgery | test group |
Primary outcome
incidence of blood spill
Time frame: when the needle was inserted
The incidence of blood spill of the control group is 80.9%, while it of the test group is 0.00%.
incidence of bruise area
Time frame: after 24 hours
The incidence of bruise area of the control group is 63.8%, while it of the test group is 13.3%.
incidence of blood clot
Time frame: during the autologous blood transfusion when checked
The incidence of blood clot of the control group is 10.6%, while it of the test group is 0.00%.
incidence of dizziness
Time frame: After blood collection
The incidence of dizziness of the control group is 2.1%, while it of the test group is 2.2%.
heart rate
Time frame: before and after blood collection
Heart rate of the control group before and after blood collection is 77.19±6.20 and 77.94±6.83 respectively. Heart rate of the test group before and after blood collection is 76.11±5.59 and 77.22±4.32 respectively.
blood pressure
Time frame: before and after blood collection
Systolic blood pressure of the control group before and after blood collection is 124.85±7.94 and 125.7±6.75 respectively. Systolic blood pressure of the test group before and after blood collection is 124.93±7.04 and 125.76±6.41 respectively. Diastolic blood pressure of the control group before and after blood collection is 77.87±5.79 and 77.43±4.29 respectively. Diastolic blood pressure of the test group before and after blood collection is 77.62±5.08 and 76.6±4.40 respectively.
patient pain score
Time frame: during blood collection
Patient pain score of the control group is 12.51±0.98. Patient pain score of the test group is 1.53±0.69.
the time required to collect 400 mL of blood
Time frame: during blood collection
The time required to collect 400 mL of blood of the control group is 766.62±83.18. The time required to collect 400 mL of blood of the test group is 481.98±69.76.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 37753340Jia L, Wang Y, Zhang W, Lin Y, Chen F, Wan Y, Fu X. Optimisation and Effect Analysis of the Blood Collection Method in Pre-Deposit Autotransfusion Patients Undergoing Thoracotomy Surgery. J Multidiscip Healthc. 2023 Sep 20;16:2793-2798. doi: 10.2147/JMDH.S424470. eCollection 2023.
- Individual participant dataSharing planned: No
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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 modified blood collection method in people with Autologous Blood Transfusion, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 1 site in China.
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 3 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 7 Dec 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of blood spill (time frame: when the needle was inserted). The study lists 8 primary outcomes in all. 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 NCT05539846, which also lists 1 linked publication.
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 7 Dec 2022.