Deep Vein ThrombosisNCT05900622
A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention
A study testing Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours and Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours in people with Deep Vein Thrombosis and Deep Venous Insufficiency, run by Tong Zhu.
Trial summary
The goal of this clinical trial is to compare in describe participant population health conditions. The main questions it aims to answer are: To obtain the limb movement and bed mobility limits after femoral venipuncture, in order to provide a basis and support for clinical reduction of postoperative braking time and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis, Deep Venous Insufficiency
- What is being tested?
- Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours and Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jun 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, no serious liver or kidney function abnormalities.
- No significant preoperative bleeding tendency or hemostatic dysfunction, platelets ≥75×109/L, prothrombin time (PT) <16 s.
- No other femoral vascular puncture procedures were performed bilaterally during the observation period.
- Normal neurological and cognitive function, able to make a correct assessment, able to move normally on the floor after surgery, informed consent and willing to cooperate.
Who cannot join
- Patients in whom this operation is combined with ipsilateral femoral artery puncture or intraoperative percutaneous puncture into the femoral artery by mistake.
- Patients with significant hematoma during femoral vein puncture or with the formation of a visually visible hematoma at the puncture site after removal of the sheath or persistent blood leakage, pseudoaneurysm, or arteriovenous fistula.
- Patients with severe insufficiency of important organs or obvious hemostasis and coagulation dysfunction.
- Patients with poor postoperative compliance or other insurmountable reasons for inability to complete the prescribed time of activity and get out of bed.
- Patients who are unwilling to sign the informed consent form after being adequately informed by the investigator about the trial.
About this study
The goal of this clinical trial is to compare in describe participant population health conditions. The main questions it aims to answer are:
- To obtain the limb movement and bed mobility limits after femoral venipuncture, in order to provide a basis and support for clinical reduction of postoperative braking time and alleviation of postoperative patient subjective discomfort
- To analyze the effect of perioperative factors such as anticoagulation and sheath size on the complication rate, so as to develop a detailed and systematic strategy to stop bleeding after femoral venipuncture
- The advantages and necessity of reducing the postoperative braking time in bed were demonstrated by objective evaluation of patients' postoperative subjective feelings and mental status.
In this prospective study, 150 patients who underwent femoral vein puncture intervention were selected by inclusion and exclusion criteria, and were randomly divided into control group, trial A group and trial B group by SPSS software, with 50 cases each. In the control group, the lower limb of the punctured side was braked for 4 hours + 8 hours after routine postoperative activities; in the trial A group, the lower limb of the punctured side was braked for 2 hours + 4 hours after postoperative activities; in the trial B group, the lower limb of the punctured side was braked for no postoperative activities + 2 hours after postoperative activities, and the corresponding evaluation indexes and questionnaires were used to record the hemostasis at the puncture site, whether complications occurred and the subjective feelings of patients in each group after completing the corresponding strategies. The data were also recorded along with the general information of the patients and the factors that may cause bleeding in the perioperative period. Statistical analysis was used to classify, summarize and draw conclusions about the data obtained, analyze the limit of braking bed time, and formulate scientific hemostatic strategies.
- Conditions
- Deep Vein Thrombosis, Deep Venous Insufficiency
- Being tested
- Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours, Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hoursOther
Braking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care
Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hoursOther
Braking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Lower extremity on the puncture side with a 4-hour brake+Get out of bed after 8 hours |
| Test group A | Experimental | Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours Receives: Other: Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours |
| Test group B | Experimental | No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours Receives: Other: Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of postoperative bleeding
he Christenson modification method [13 was applied to classify the degree of bleeding into normal, non-significant bleeding, and significant bleeding. (1) Normal: no visible bloody exudate on the dressing; (2) Non-significant bleeding: a small amount of localized bleeding, no palpable hematoma or hematoma <5 cm, no special treatment required; (3) Significant bleeding: more bleeding from the dressing, estimated bleeding volume >100 ml, hematoma and skin petechiae >5 cm in diameter, hematoma compression affecting dorsalis pedis artery pulsation, requiring manual compression, sandbag compression or re Compression dressing
Measured: 8 hours after surgery
Secondary outcomes (3)
Postoperative pain level
The numeric rating scale (NRS) was used to assess the pain level of each group of patients from 4 to 6 h after surgery. 0 indicates no pain, 1 to 3 indicates mild pain, 4 to 6 indicates moderate pain, 7 to 9 indicates severe pain, and 10 indicates severe pain, which was rated by patients based on subjective feelings.
Measured: 6 hours after surgery
Postoperative anxiety level
The Hamilton Anxiety Scale (HAMA) was used to assess the anxiety level of each group of patients at 4-6 h postoperatively. A HAMA score of <7 indicates no anxiety, ≥7 indicates possible anxiety, ≥14 indicates definite anxiety, ≥21 indicates definite significant anxiety, and ≥29 indicates severe anxiety.
Measured: 6 hours after surgery
Postoperative comfort level
The kolcaba Comfort Questionnaire (GCQ) was used to assess the comfort level of each group of patients at 4-6 h postoperatively. The higher the GCQ score, the better the comfort level.
Measured: 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tong Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tong Zhu, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900622
- Sponsor's protocol ID
- [2023]23th
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 12 Jun 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention
- ClinicalTrials.gov ID
- NCT05900622
- Acronym / sponsor ID
- [2023]23th
- Conditions
- Deep Vein Thrombosis, Deep Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tong ZhuUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
The goal of this clinical trial is to compare in describe participant population health conditions. The main questions it aims to answer are:
- To obtain the limb movement and bed mobility limits after femoral venipuncture, in order to provide a basis and support for clinical reduction of postoperative braking time and alleviation of postoperative patient subjective discomfort
- To analyze the effect of perioperative factors such as anticoagulation and sheath size on the complication rate, so as to develop a detailed and systematic strategy to stop bleeding after femoral venipuncture
- The advantages and necessity of reducing the postoperative braking time in bed were demonstrated by objective evaluation of patients' postoperative subjective feelings and mental status.
In this prospective study, 150 patients who underwent femoral vein puncture intervention were selected by inclusion and exclusion criteria, and were randomly divided into control group, trial A group and trial B group by SPSS software, with 50 cases each. In the control group, the lower limb of the punctured side was braked for 4 hours + 8 hours after routine postoperative activities; in the trial A group, the lower limb of the punctured side was braked for 2 hours + 4 hours after postoperative activities; in the trial B group, the lower limb of the punctured side was braked for no postoperative activities + 2 hours after postoperative activities, and the corresponding evaluation indexes and questionnaires were used to record the hemostasis at the puncture site, whether complications occurred and the subjective feelings of patients in each group after completing the corresponding strategies. The data were also recorded along with the general information of the patients and the factors that may cause bleeding in the perioperative period. Statistical analysis was used to classify, summarize and draw conclusions about the data obtained, analyze the limit of braking bed time, and formulate scientific hemostatic strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Lower extremity on the puncture side with a 4-hour brake+Get out of bed after 8 hours |
| Test group A | Experimental | Other: Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hoursLower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours |
| Test group B | Experimental | Other: Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hoursNo braking of the lower limb on the side of the puncture+Get out of bed after 2 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old, no serious liver or kidney function abnormalities.
- No significant preoperative bleeding tendency or hemostatic dysfunction, platelets ≥75×109/L, prothrombin time (PT) <16 s.
- No other femoral vascular puncture procedures were performed bilaterally during the observation period.
- Normal neurological and cognitive function, able to make a correct assessment, able to move normally on the floor after surgery, informed consent and willing to cooperate.
Key exclusion criteria (5 listed)
- Patients in whom this operation is combined with ipsilateral femoral artery puncture or intraoperative percutaneous puncture into the femoral artery by mistake.
- Patients with significant hematoma during femoral vein puncture or with the formation of a visually visible hematoma at the puncture site after removal of the sheath or persistent blood leakage, pseudoaneurysm, or arteriovenous fistula.
- Patients with severe insufficiency of important organs or obvious hemostasis and coagulation dysfunction.
- Patients with poor postoperative compliance or other insurmountable reasons for inability to complete the prescribed time of activity and get out of bed.
- Patients who are unwilling to sign the informed consent form after being adequately informed by the investigator about the trial.
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 |
|---|---|---|
| Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hoursBraking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care | Other | Test group A |
| Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hoursBraking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care | Other | Test group B |
Primary outcome
Degree of postoperative bleeding
Time frame: 8 hours after surgery
he Christenson modification method [13 was applied to classify the degree of bleeding into normal, non-significant bleeding, and significant bleeding. (1) Normal: no visible bloody exudate on the dressing; (2) Non-significant bleeding: a small amount of localized bleeding, no palpable hematoma or hematoma <5 cm, no special treatment required; (3) Significant bleeding: more bleeding from the dressing, estimated bleeding volume >100 ml, hematoma and skin petechiae >5 cm in diameter, hematoma compression affecting dorsalis pedis artery pulsation, requiring manual compression, sandbag compression or re Compression dressing
3 secondary outcomes
Postoperative pain level
Time frame: 6 hours after surgery
Postoperative anxiety level
Time frame: 6 hours after surgery
Postoperative comfort level
Time frame: 6 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours and Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours in people with Deep Vein Thrombosis and Deep Venous Insufficiency, run by Tong Zhu.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Degree of postoperative bleeding (time frame: 8 hours after surgery). 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 12 Jun 2023; AzTrials last refreshed its copy on 4 Nov 2026.