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BleedingNCT03909711

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

An observational study of Bleeding and Anemia, run by University of Roma La Sapienza at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bleeding, Anemia
How many people
100 participants
Where
1 siteItaly
Study dates
15 May 2019to Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients undergoig elective mulilevel spine surgery

Who may be able to join

  • adults (age> 18)
  • ASA I-III
  • elective spinal surgery
  • multi-level surgery

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Federico Bilotta, MD, PhD contact

3393370822

bilotta@tiscali.it

Sergio Terracina, MS contact

3387629678

sergioterracina94@gmail.com

Italy1 site
  • Azienda Policlinico Umberto I, University of Rome La Sapienza,

    Rome, 00161

    Federico Bilotta, MD, PhD, 3393370822, bilotta@tiscali.it

    Federico Bilotta, MD, PhD

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Bleeding, Anemia
Keywords
Temperature, Bleeding, Anemia, Spine
Medical subject headings
Hemorrhage, Anemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: the investigators are recruiting patients from November 2018 to November 2019

Secondary outcomes (1)
  1. Infections and complications related to bleeding

    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

    Measured: the investigators are recruiting patients from November 2018 to November 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study start15 May 2019 (estimated)
  3. Primary completionSep 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03909711
Sponsor's protocol ID
5031
Status last verified
Apr 2019
First submitted
29 Mar 2019
Last updated
10 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bleeding and Anemia, run by University of Roma La Sapienza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Federico Bilotta, MD, PhD (3393370822, bilotta@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between temperature and bleeding (time frame: the investigators are recruiting patients from November 2018 to November 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.

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