Clinic Trial for Peri-operative Transfusion Trigger Score (POTTS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Liu Jin, West China Hospital
ClinicalTrials.gov Identifier:
NCT01597232
First received: May 9, 2012
Last updated: May 13, 2012
Last verified: May 2012
  Purpose

Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.

Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.


Condition Intervention Phase
Transfusion Related Complications
Other: Transfusion trigger based on POTTS
Other: Maintenance of hemoglobin level more than 10g/dL
Other: Transfusion trigger based on experience
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Clinic Trial for Evaluation of Safety and Efficacy of Peri-operative Transfusion Trigger Score (POTTS)

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • Incidence of death and serious complications [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Transfusion rate and transfusion volume of red blood cells [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of ICU stay [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Hemoglobin level postoperatively [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]
  • Healing of surgical incision [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]
  • Length of hospitalization [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Cost of transfusion and hospitalization [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: one year postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transfusion trigger based on POTTS
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on POTTS.
Other: Transfusion trigger based on POTTS
Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on POTTS
Active Comparator: Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively.
Other: Maintenance of hemoglobin level more than 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively
Active Comparator: Transfusion trigger based on experience
Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience.
Other: Transfusion trigger based on experience
Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Height of usual place of residence less than 2,500 metres above sea level
  • Perioperative hemoglobin level possibly less than 10g/dL

Exclusion Criteria:

  • Emergency operation
  • ASA classification V or VI
  • Serious blood system diseases
  • Dysfunction of hemoglobin
  • Hypervolemic hemodilution
  • Tumor metastasis
  • Psychopathy
  • Refuse to sign consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597232

Locations
China, Sichuan
Department of Anesthesiology, West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
Study Director: Ren Liao, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
Principal Investigator: Jin Liu, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
  More Information

No publications provided

Responsible Party: Liu Jin, Chief of Department of Anesthesiology, West China Hospital
ClinicalTrials.gov Identifier: NCT01597232     History of Changes
Other Study ID Numbers: POTTS120508
Study First Received: May 9, 2012
Last Updated: May 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by West China Hospital:
Transfusion trigger
Hemoglobin level

ClinicalTrials.gov processed this record on August 01, 2014