- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580965
Blood Sample Collection in Geriatric Patients
November 20, 2023 updated by: Tulay Basak, Saglik Bilimleri Universitesi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
164
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06010
- Tulay Basak
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
61 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Routine procedure
|
|
|
Experimental: Group A
1 min pressure applied
|
After blood collection, 20 N pressure applied for 1 minute
|
|
Experimental: Group B
3 min pressure applied
|
After blood collection, 20 N pressure applied for 3 minute
|
|
Experimental: Group C
5 min pressure applied
|
After blood collection, 20 N pressure applied for 5 minute
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the 24 th hours
|
|
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.
|
at the 48 th hours
|
|
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.
|
at the 72 nd hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tulay Basak, Saglik Bilimleri Universitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2021
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 12, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 779
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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