Venipuncture Site BruiseNCT05580965
Blood Sample Collection in Geriatric Patients
A study testing 20 N pressure for 1 minute, 20 N pressure for 3 minute and 20 N pressure for 5 minute in people with Venipuncture Site Bruise, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants. Read more about this study
- Who is it for?
- Ages 65 to 93 years
- Conditions the study is for
- Venipuncture Site Bruise
- What is being tested?
- 20 N pressure for 1 minute, 20 N pressure for 3 minute and 20 N pressure for 5 minute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2021to 15 Jun 2022
- 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 65 to 93 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients aged 65 years and over
- who voluntarily agreed to participate in the study
- who used oral (Rivaroxaban 10-15-20 mg, Dabigatran, 75-110-150 mg, Apixaban 2.5-5 mg) and subcutaneous (Enoxaparin sodium 6000-4000 anti-Xa IU/0.6-0.4 ml) anticoagulants
- who were literate in Turkish
- who were scheduled for blood collection
- who would undergo blood collection from the antecubital site with vacutainer
Who cannot join
- patients with communication problems
- patients with hematoma, ecchymosis, and scarring in the antecubital site
- patients who would be discharged before 72 hours
- patients with coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Duration of Pressure Applied After Blood Sample Collection on the Development of Ecchymosis in Geriatric Patients Using Oral and Subcutaneous Anticoagulants: A Randomized Controlled Trial
This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants.
Read the detailed description
The research sample consisted of patients hospitalized in the Geriatrics Clinic of a city hospital. This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants. In this study, whether ecchymosis developed at the 24th, 48th and 72nd hours after the blood collection procedure was evaluated.
- Conditions
- Venipuncture Site Bruise
- Being tested
- 20 N pressure for 1 minute, 20 N pressure for 3 minute, 20 N pressure for 5 minute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 N pressure for 1 minuteOther
After blood collection, 20 N pressure applied for 1 minute
20 N pressure for 3 minuteOther
After blood collection, 20 N pressure applied for 3 minute
20 N pressure for 5 minuteOther
After blood collection, 20 N pressure applied for 5 minute
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Routine procedure |
| Group A | Experimental | 1 min pressure applied Receives: Other: 20 N pressure for 1 minute |
| Group B | Experimental | 3 min pressure applied Receives: Other: 20 N pressure for 3 minute |
| Group C | Experimental | 5 min pressure applied Receives: Other: 20 N pressure for 5 minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with ecchymosis developed.
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
Measured: at the 24 th hours
number of participants with ecchymosis developed.
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
Measured: at the 48 th hours
number of participants with ecchymosis developed.
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
Measured: at the 72 nd hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start30 Oct 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venipuncture Site BruiseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulay Basak, Saglik Bilimleri Universitesi
- Investigators
- Tülay Başak, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580965
- Sponsor's protocol ID
- 779
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Duration of Pressure Applied After Blood Sample Collection on the Development of Ecchymosis in Geriatric Patients Using Oral and Subcutaneous Anticoagulants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05580965
- Acronym / sponsor ID
- 779
- Conditions
- Venipuncture Site Bruise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 14 Oct 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.
This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants.
Detailed description
The research sample consisted of patients hospitalized in the Geriatrics Clinic of a city hospital. This study aimed to evaluate the effect of different durations of a specific pressure applied after blood collection on the development of ecchymosis in geriatric patients using oral and subcutaneous anticoagulants. In this study, whether ecchymosis developed at the 24th, 48th and 72nd hours after the blood collection procedure was evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Routine procedure |
| Group A | Experimental | Other: 20 N pressure for 1 minute1 min pressure applied |
| Group B | Experimental | Other: 20 N pressure for 3 minute3 min pressure applied |
| Group C | Experimental | Other: 20 N pressure for 5 minute5 min pressure applied |
Who may qualify
- Ages
- 65 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- patients aged 65 years and over
- who voluntarily agreed to participate in the study
- who used oral (Rivaroxaban 10-15-20 mg, Dabigatran, 75-110-150 mg, Apixaban 2.5-5 mg) and subcutaneous (Enoxaparin sodium 6000-4000 anti-Xa IU/0.6-0.4 ml) anticoagulants
- who were literate in Turkish
- who were scheduled for blood collection
Key exclusion criteria (4 listed)
- patients with communication problems
- patients with hematoma, ecchymosis, and scarring in the antecubital site
- patients who would be discharged before 72 hours
- patients with coagulation disorders
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 |
|---|---|---|
| 20 N pressure for 1 minuteAfter blood collection, 20 N pressure applied for 1 minute | Other | Group A |
| 20 N pressure for 3 minuteAfter blood collection, 20 N pressure applied for 3 minute | Other | Group B |
| 20 N pressure for 5 minuteAfter blood collection, 20 N pressure applied for 5 minute | Other | Group C |
Primary outcome
number of participants with ecchymosis developed.
Time frame: at the 24 th hours
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
number of participants with ecchymosis developed.
Time frame: at the 48 th hours
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
number of participants with ecchymosis developed.
Time frame: at the 72 nd hours
In this study, whether ecchymosis developed at the 24th, 48th, and 72nd hours after the blood collection procedure was evaluated.
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 21 Nov 2023.
- Individual participant dataSharing planned: No
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.
Tülay Başak principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 N pressure for 1 minute, 20 N pressure for 3 minute and 20 N pressure for 5 minute in people with Venipuncture Site Bruise, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 21 Nov 2023. 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 Turkey (Türkiye). 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?
number of participants with ecchymosis developed. (time frame: at the 24 th hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.