ClinicalTrials.gov
ClinicalTrials.gov Menu

A Survey on Blood Transfusions in Major Artrhoplasty Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03282201
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Brief Summary:

The rate of hip, knee arthroplasties and their revision are increasing every year. The incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%, respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and thromboembolic complications and is related to mortality. Restrictive transfusion protocols has cost-effective results in terms of reducing these complications, promoting early discharge and reduced frequency of re-admission.

Within this context, we aimed to evaluate the transfusion practice in our hospital, define the transfusion indicators and compare the transfused and non transfused patients in terms of recovery.


Condition or disease Intervention/treatment
Arthropathy of Hip Arthropathy of Knee Other: Transfusion

Detailed Description:

After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision arthroplasty will be included in this prospective observational study.

Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the precence of preoperative anemia, anemia treatment modalities will be recorded.

Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of patients Early upright position (postoperative 2nd day), information on walking capacities (TUG - The Time Up and Go test) will be recorded and compared between transfused and non-transfused patients


Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Effect of Blood Transfusion on Recovery After Major Arthroplasties
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Transfused
Patients in whom blood transfusion is used
Other: Transfusion
Transfusion of red blood cells, fresh frozen plasma, platelets

Nontransfused
Patients in whom blood transfusion is not used



Primary Outcome Measures :
  1. Discharge time [ Time Frame: Postoperative day 1-6 days ]
    Discharge time from hospital

  2. TUG test [ Time Frame: Postoperative day 1-2 ]
    Walking without help



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major atrhroplasty
Criteria

Inclusion Criteria:

  • Patients undergoing major atrhroplasty

Exclusion Criteria:

  • Pediatric patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282201


Contacts
Contact: Dilek Yazicioglu, Assoc Prof +905336957855 dilek.yazicioglu@hotmail.com

Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Dilek Yazicioglu, Assoc Prof Netherlands: Ministry of Health, Welfare and Sports