Status:

UNKNOWN

Comparison of Active and Passive Perioperative Warming Techniques in Reducing Intraoperative Blood Loss

Lead Sponsor:

Peking Union Medical College Hospital

Collaborating Sponsors:

3M

Conditions:

Hypothermia

Blood Loss,

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a randomized, open label, parallel two arm, clinical study, which compare the Bair Hugger forced-air warming blanket and the conventional warming care practice in China on patients undergoing ...

Detailed Description

Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air Warming System to assess the contraindications, warnings, and precaution sections with respect to risks and b...

Eligibility Criteria

Inclusion

  • Adult patients≥18 years old
  • Preoperative core temperature between 36.0 and 37.5°C
  • American Society of Anaesthesiologists(ASA) Physical Status Classification System I-III
  • No transdermal meds on the target site
  • Elective major surgeries included but not limited:
  • Hip replacement
  • Thoracic surgery (lobectomy and esophagectomy) or abdominal surgery

Exclusion

  • Less than 18 years old
  • Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose \>250 mg/dL)
  • A preoperative temperature above 37.5°C or less than 36°C
  • Hyperthyroidism and hypothyroidism
  • Raynaud disease
  • History of infection and fever within 4 weeks before surgery
  • Use of steroid or immunosuppressant within 4 weeks before surgery
  • History of bleeding disorders
  • Clinically significant laboratory abnormalities
  • Hgb ≤ 10.0 g/L
  • Platelets ≤ 100,000 / mL
  • WBC(white blood cell ) \<3000/dL
  • Fibrinogen\<200 mg/dL
  • Thromboplastin time\>40s
  • Prothrombin time
  • international normalized ratio(INR)\<70%

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2015

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02214524

Start Date

August 1 2014

End Date

January 1 2015

Last Update

August 18 2014

Active Locations (1)

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100000