Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery

April 8, 2019 updated by: Federico Bilotta, University of Roma La Sapienza

Relationship Between Temperature and Intraoperative Bleeding in Patients Undergoing Multilevel Spinal Surgery: Prospective, Multicenter Study

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.

Study Overview

Status

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Rome,, Italy, 00161
        • Azienda Policlinico Umberto I, University of Rome La Sapienza,
        • Principal Investigator:
          • Federico Bilotta, Md, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients undergoig elective mulilevel spine surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 5031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Anemia

3
Subscribe