Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio... | NCT05636163

Studies
Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting

NCT05636163

Sponsor

Qianfoshan Hospital

Status

Unknown status

Last Update Posted

Dec 5, 2022Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Hemophilia A

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Estimated

Primary Completion Date

Jan 20, 2023Estimated

Completion Date

Feb 20, 2023Estimated

First Submitted Date

Nov 17, 2022

First Submission Date that Met QC Criteria

Dec 2, 2022

First Posted Date

Dec 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2022

Last Update Posted Date

Dec 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	up to 24 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
The amount of postoperative antiemetics	antiemetics includes ondansetron, metoclopramide, dexamethasone	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).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuelan Wang	Contact	15953105780		wyldgf@163.com

Overall Officials

Name	Affiliation	Role
Yuelan Wang	China, Shandong Qianfoshan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Provincial Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University		Jinan	Shandong	250000	China

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D014839	Vomiting

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

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