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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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000