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Perioperative Transfusion Related Outcome

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: NCT03930355
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Brief Summary:
A secondary analysis of the Turkish National Perioperative Transfusion Study (TULIP TS) database will be performed.

Condition or disease Intervention/treatment
Blood Transfusion Other: Blood transfusion Other: Control

Detailed Description:

The Turkish National Perioperative Transfusion Study (TULIP TS) was conducted by The Turkish Society of Anesthesiologists' Multicentre Clinical Trials Network.

TULIP TS included 6481 patients undergoing major elective surgery, from 61 study sites across the country.

Transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and patient blood management strategies; the areas for improvement and the obstacles that could prevent change were evaluated and identified.

Data relevant to perioperative transfusion rates of red blood cells, fresh frozen plasma and platelets, the indications for transfusion and postoperative adverse outcomes including 1 month all cause mortality was obtained.

The TULIP TS group aims to collect further data concerning 1 year all cause mortality of the same patient population and to evaluate adverse outcomes in transfused and non transfused patients.

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Study Type : Observational
Estimated Enrollment : 6481 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Perioperative Transfusion on Early and Late Outcome After Major Elective Surgery
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Transfused
Patients who received blood transfusion in the perioperative period
Other: Blood transfusion
Patients who received blood transfusion in the perioperative period

Non transfused
Patients who did not receive blood transfusion in the perioperative period
Other: Control
Patients who did not receive blood transfusion in the perioperative period




Primary Outcome Measures :
  1. 1 year all cause mortality [ Time Frame: postoperative 366th day ]
    Number of participants died: all cause mortality

  2. Acute kidney injury [ Time Frame: postoperative 30th day ]
    Number of participants with acute kidney injury

  3. Acute respiratory failure [ Time Frame: postoperative 30th day ]
    Number of participants with acute respiratory failure

  4. Thromboembolic event [ Time Frame: postoperative 30th day ]
    Number of participants with a thromboembolic event

  5. Ischemic event [ Time Frame: postoperative 30th day ]
    Number of participants with an ischemic event

  6. Infection [ Time Frame: postoperative 30th day ]
    Number of participants with infection

  7. Myocardial infarction [ Time Frame: postoperative 30th day ]
    Number of participants with myocardial infarction

  8. Adverse cardiac event [ Time Frame: postoperative 30th day ]
    Number of participants with an adverse cardiac event



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery
Criteria

Inclusion Criteria:

• Patients undergoing major elective surgery

Exclusion Criteria:

• Trauma patients, emergency surgery


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): NCT03930355


Contacts
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Contact: Dilek Ünal 05336957855 dilek.yazicioglu@hotmail.com

Locations
Show Show 60 study locations
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Principal Investigator: Dilek Ünal Netherlands: Ministry of Health, Welfare and Sports
Publications of Results:
Other Publications:
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Responsible Party: DILEK YAZICIOGLU, Assoc Prof, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT03930355    
Other Study ID Numbers: TULIP TS II
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:
Surgery
Perioperative
Transfusion
Mortality