- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909711
Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery
Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery: Prospective, Multicenter Study
Study Overview
Detailed Description
In this prospective, observational, multicentric study, after ethics committee approval and patients informed consent, 20 patients for each center undergoing elective multi-level spine surgery procedures will be enrolled. A total of 80 patients will be enrolled. No randomization or concealment is planned.
Inclusion criteria are: adults (age> 18), American Society of Anesthesiologists (ASA) I-III, undergoing elective multi-level spinal surgery intervention. Patients with 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. Other exclusion criteria are: emergency intervention, known coagulopathy and chronic preoperative anemia.
Temperature will be measured with tympanic, anal or esophageal probe according to the availability and means of the department. Variables related to the patient (such as sex, age, BMI, smoke, anticoagulant or antiplatelet therapy in progress, presence of mild chronic hepatopathy / cardiopathy / pneumopathy / renal failure, hemoglobin and the preoperative hematocrit) will be compared with type and length of intervention, estimated blood loss, intraoperative variables (such as diuresis, minimum temperature and its variations, blood transfusions, ventilation mode) and post- operative hemoglobin level (the day after operation) to assess patient prognosis in terms of need for transfusion and infectious and respiratory complications incidence 7 days after surgery.
For each patient will be measured initial intraoperative temperature (T0) and minimum temperature (Tmin) with esophageal, anal or tympanic probe every 30 minutes during surgery. The temperature delta will be calculated as T0 - Tmin.
the investigators will compare intraoperative reduction of basal body temperature with Hb level reduction (preoperative Hb compared to Hb of the following day of intervention) considering as significant a temperature reduction of at least 1 ° C and Hb reduction of at least 1 g/dl, net of variables recognized correlated with increased bleeding in vertebral surgery (age, sex, diabetes mellitus, smoking, arterial hypertension, ASA class, intervention time, preoperative Ht) and liquid volume infused during intervention (hemodilution).
The continuous variables will be presented as mean and standard deviation while the categorical ones as frequency (percentage frequency, %).
Univariate logistic regression analysis will be applied to evaluate the effect of patients variables, surgical intervention with anesthesia management on patients prognosis in terms of need for transfusion and presence / absence of infectious and respiratory complications 7 days after surgery Variables associated with the need for transfusion and 7-day complications with p value <0.10 on univariate analysis will be considered in a multivariate logistic regression analysis model. The area under the receiver ROC curve (AUC) will be used as a measure of the model's prediction capacity.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Federico Bilotta, MD, PhD
- Phone Number: 3393370822
- Email: bilotta@tiscali.it
Study Contact Backup
- Name: Sergio Terracina, MS
- Phone Number: 3387629678
- Email: sergioterracina94@gmail.com
Study Locations
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-
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Rome,, Italy, 00161
- Azienda Policlinico Umberto I, University of Rome La Sapienza,
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Principal Investigator:
- Federico Bilotta, Md, PhD
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Contact:
- Federico Bilotta, MD, PhD
- Phone Number: 3393370822
- Email: bilotta@tiscali.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults (age> 18)
- ASA I-III
- elective spinal surgery
- multi-level surgery
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between temperature and bleeding
Time Frame: the investigators are recruiting patients from November 2018 to November 2019
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infections and complications related to bleeding
Time Frame: the investigators are recruiting patients from November 2018 to November 2019
|
the investigators evaluate, with 1 week follow up, if there is any correlation between infections or other complications (pulmonary events, cardiac events...) and the bleeding of the patients
|
the investigators are recruiting patients from November 2018 to November 2019
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5031
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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