Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery
1 other identifier
observational
100
1 country
1
Brief Summary
The primary objective of this multicentric observational study is to define the role of intraoperative temperature decrease (defined as reduction of at least 1 ° C during surgery) as haemorrhagic risk factor, evaluated as reduction of at least 1 gr / dl of hemoglobin, and to correlate it with the need for transfusion. Secondary objectives are infections and complications affecting other organs and systems incidence in the first week after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedApril 10, 2019
April 1, 2019
4 months
March 29, 2019
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
correlation between temperature and bleeding
the investigators aim to evaluate if temperature influence the bleeding of patients and which temperature seems to be the best (normothermia versus hypothermia). the investigators consider as significant bleeding the lost of at least 1 point of hemoglobin (lost \>1mg/dl), and hypothermia the loss of at least 1°C of the body temperature
the investigators are recruiting patients from November 2018 to November 2019
Secondary Outcomes (1)
Infections and complications related to bleeding
the investigators are recruiting patients from November 2018 to November 2019
Eligibility Criteria
Adult patients undergoig elective mulilevel spine surgery
You may qualify if:
- adults (age\> 18)
- ASA I-III
- elective spinal surgery
- multi-level surgery
You may not qualify if:
- significant comorbidities such as severe liver disease, severe renal disease (stage III-IV), heart disease with organ failure, severe preoperative anemia requiring blood transfusions, severe pneumopathy with high probability of postoperative prolonged mechanical ventilation are excluded
- emergency intervention
- known coagulopathy
- chronic preoperative anemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Policlinico Umberto I, University of Rome La Sapienza,
Rome, 00161, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Phisician Doctor
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 10, 2019
Study Start
May 15, 2019
Primary Completion
September 1, 2019
Study Completion
November 1, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04