Clinical Trial of West-China Perioperative Transfusion Score (WCPTS）for Massive Hemorrhagic Surgery

NCT01345643 | Completed DMC

• 1 other identifier: WCPTS110419
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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 7\~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/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 7/dL and 10g/dL could be calculated by their history about heart and blood pressure, and routine monitoring parameters including pulse oximetry, temperature, and the use of vasoactive medications. 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.

Conditions

Transfusion Related Complications

Keywords

Transfusion; Hemoglobin level

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who received red blood cells transfusion

  Proportion of patients who received red blood cells transfusion (Patients received red cells transfusion/ total number of the patients)

  Up to 12 weeks.

• Transfusion volume of red blood cells

  Volume of red blood cells transfused to the patients (units)

  Up to 12 weeks.

Secondary Outcomes (8)

• All-cause mortality in 30 days post-operatively

  Up to 30 days post-operatively.

• In-hospital complications

  Up to 12 weeks.

• Hb level at different time points

  Up to 12 weeks.

• Length of ICU stay and hospitalization

  Up to 12 weeks.

• Costs of hospitalization and transfusion

  Up to 12 weeks.

Study Arms (2)

Hemoglobin level based on WCPTS

EXPERIMENTAL

According to WCPTS, the patient's hemoglobin level will be maintained not less than 7,8,9,or 10g/dL. Determination of whether a patient need red blood cells transfusion is based on WCPT Score.

Other: Transfusion trigger based on WCPTS

Hemoglobin level 10g/dL

ACTIVE COMPARATOR

The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.

Other: Maintenance of hemoglobin level not less than 10g/dL

Interventions

Maintenance of hemoglobin level not less than 10g/dL OTHER

The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.

Hemoglobin level 10g/dL

Transfusion trigger based on WCPTS OTHER

Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS

Hemoglobin level based on WCPTS

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 15years to 70years.
• American Society of Anesthesiologists (ASA) physical status I, II, Ⅲ or Ⅳ.
• Undergoing elective spine surgery with estimated blood loss more than 800ml or 20% of the patient's whole blood volume.
• Glasgow Coma Scale (GCS) score of 15.
• Ability to communicate by telephone call.
• Informed consent has been signed by the patient or his legal guardian.

You may not qualify if:

• Declined to receive blood transfusion.
• Refuse to sign consent.
• Pregnancy.
• Psychopathy.
• Coagulopathy.
• Impairment of communication or cognition.
• Active participation in another trial where the primary endpoint follow-up is ongoing.
• Unwillingness or inability to comply with protocol procedures.

Sponsors & Collaborators

• Ren Liao: lead

Study Sites (1)

West China Hosptial, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Ren Liao, M.D.

  Department of Anesthesiology, West China Hospital, Sichuan University

  STUDY DIRECTOR

• Jin Liu, M.D.

  Department of Anesthesiology, West China Hospital, Sichuan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor of Department of Anesthesiology

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: May 2, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: February 1, 2014
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)