Hemophilia ANCT05636163
Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting
An observational study of Hemophilia A, run by Qianfoshan Hospital at 1 site in China.
Trial summary
By comparing the incidence of PONV, the dosage of postoperative antiemetic drugs, the postoperative VAS score and the utilization rate of PCIA of hemophilia A patients in the NLR≥2 and NLR<2 groups, investigators could find out the high value in the diagnosis of hemophilia A, which is helpful to guide the clinical… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hemophilia A
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 20 Feb 2023
- Phase
- Observational
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Hemophilia A patients who underwent single knee replacement under general anesthesia in the First Affiliated Hospital of Shandong First Medical University from March 2018 to February 2022
Who may be able to join
- The patients with hemophilia A undergoing unilateral total knee arthroplasty.
- The age of the patients ranged from 18 to 70 years.
- American Society of Anesthesiologists is graded as I~III
- No history of mental illness
- No history of antiemetic and anticholinergic drugs.
- No history of serious gastrointestinal diseases.
Who cannot join
- Patients who have received long-term steroid treatment
- Patients who need more than 2.5 mg neostigmine to reverse muscle relaxants
- Patients with previous malignant tumor, malabsorption, morbid obesity, hypogonadism, thyroid and parathyroid diseases and autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: The Effectiveness of Preoperative Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting After Total Knee Replacement in Hemophilia A
By comparing the incidence of PONV, the dosage of postoperative antiemetic drugs, the postoperative VAS score and the utilization rate of PCIA of hemophilia A patients in the NLR≥2 and NLR<2 groups, investigators could find out the high value in the diagnosis of hemophilia A, which is helpful to guide the clinical diagnosis and treatment of hemophilia A.
Read the detailed description
Hemophilia arthropathy is a debilitating complication of hemophilia that occurs primarily in severe forms with recurrent spontaneous intra-articular hemorrhage, with the knee being the most commonly affected joint. Currently, total knee arthroplasty is the standard treatment for end-stage hemophilic arthropathy. Due to the special disease of hemophilia, general anesthesia is often chosen as the preferred anesthesia method, and the risk of bleeding is lower than that of neuraxial anesthesia. However, 20 to 30 percent of surgical patients suffer from post-operative nausea and vomiting after general anesthesia. Neutrophil to lymphocyte ratio and platelet to lymphocyte ratio have been suggested as parameters for the diagnosis and follow-up of inflammatory diseases, and inflammation has been found to increase the risk of PONV. However, for patients with hemophilia, no information is currently available on the relationship between the two. In this study, investigators intend to retrospectively analyze the clinical data of patients with hemophilia A in our hospital, explore the clinical value of preoperative NLR and PLR in predicting nausea and vomiting after TKA.
- Conditions
- Hemophilia A
- Keywords
- Neutrophil, Lymphocyte, Platelet, Hemophilia, Post-operative nausea and vomiting
- Medical subject headings
- Hemophilia A, Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty
PONV was defined as the onset of nausea or vomiting within 24 hours after surgery
Measured: up to 24 hours after surgery
Secondary outcomes (3)
The amount of postoperative antiemetics
antiemetics includes ondansetron, metoclopramide, dexamethasone
Measured: up to 24 hours after surgery
VAS score after returning to the ward
postoperative pain can be evaluated using the visual analogue scale (0-10 score, 0: no pain, 10: worst imaginable pain).
Measured: immediately after returning to the ward
Usage of PCIA
the use of postoperative patient controlled intravenous analgesia
Measured: up to 24 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 posted5 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion20 Jan 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yuelan Wang, Principal investigator, China, Shandong Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636163
- Sponsor's protocol ID
- neutrophil-to-lymphocyte ratio
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Preoperative Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting After Total Knee Replacement in Hemophilia A
- ClinicalTrials.gov ID
- NCT05636163
- Acronym / sponsor ID
- neutrophil-to-lymphocyte ratio
- Conditions
- Hemophilia A
- Keywords
- Neutrophil, Lymphocyte, Platelet, Hemophilia, Post-operative nausea and vomiting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 5 Dec 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.
By comparing the incidence of PONV, the dosage of postoperative antiemetic drugs, the postoperative VAS score and the utilization rate of PCIA of hemophilia A patients in the NLR≥2 and NLR<2 groups, investigators could find out the high value in the diagnosis of hemophilia A, which is helpful to guide the clinical diagnosis and treatment of hemophilia A.
Detailed description
Hemophilia arthropathy is a debilitating complication of hemophilia that occurs primarily in severe forms with recurrent spontaneous intra-articular hemorrhage, with the knee being the most commonly affected joint. Currently, total knee arthroplasty is the standard treatment for end-stage hemophilic arthropathy. Due to the special disease of hemophilia, general anesthesia is often chosen as the preferred anesthesia method, and the risk of bleeding is lower than that of neuraxial anesthesia. However, 20 to 30 percent of surgical patients suffer from post-operative nausea and vomiting after general anesthesia. Neutrophil to lymphocyte ratio and platelet to lymphocyte ratio have been suggested as parameters for the diagnosis and follow-up of inflammatory diseases, and inflammation has been found to increase the risk of PONV. However, for patients with hemophilia, no information is currently available on the relationship between the two. In this study, investigators intend to retrospectively analyze the clinical data of patients with hemophilia A in our hospital, explore the clinical value of preoperative NLR and PLR in predicting nausea and vomiting after TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemophilia A patients who underwent single knee replacement under general anesthesia in the First Affiliated Hospital of Shandong First Medical University from March 2018 to February 2022
Key inclusion criteria (6 listed)
- The patients with hemophilia A undergoing unilateral total knee arthroplasty.
- The age of the patients ranged from 18 to 70 years.
- American Society of Anesthesiologists is graded as I~III
- No history of mental illness
- No history of antiemetic and anticholinergic drugs.
Key exclusion criteria (3 listed)
- Patients who have received long-term steroid treatment
- Patients who need more than 2.5 mg neostigmine to reverse muscle relaxants
- Patients with previous malignant tumor, malabsorption, morbid obesity, hypogonadism, thyroid and parathyroid diseases and autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty
Time frame: up to 24 hours after surgery
PONV was defined as the onset of nausea or vomiting within 24 hours after surgery
3 secondary outcomes
The amount of postoperative antiemetics
Time frame: up to 24 hours after surgery
VAS score after returning to the ward
Time frame: immediately after returning to the ward
Usage of PCIA
Time frame: up to 24 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 5 Dec 2022.
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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.
Yuelan Wang principal investigator
China, Shandong Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Qianfoshan Hospital 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 6 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: status not confirmed, as of the sponsor's last update on 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuelan Wang (15953105780, wyldgf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PONV in patients with hemophilia A receiving general anesthesia orders for knee arthroplasty (time frame: up to 24 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 5 Dec 2022.