Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty

NCT02747615 | Completed Phase 4 Results

• 1 other identifier: 586
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.

Conditions

Revision Total Hip Arthroplasty (RTHA)

Keywords

Autologous blood donation, allogeneic blood transfusion

Outcome Measures

Primary Outcomes (1)

• Number of Transfused Allogeneic Blood Units (in Digits).

  48-72 hours after surgery.

Secondary Outcomes (1)

• Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).

  48-72 hours after surgery.

Study Arms (2)

Control group (n=30)

OTHER

The control group, which consisted of 30 patients who were transfused only allogeneic blood.

Other: transfused only allogeneic blood.

Preoperative blood donation (n=30)

ACTIVE COMPARATOR

the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.

Other: transfused pre-operatively donated autologous blood.; Drug: intravenous tranexamic acid (TXA) infusion

Interventions

transfused pre-operatively donated autologous blood. OTHER

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion

Also known as: Pre-operative autologous donation

Preoperative blood donation (n=30)

intravenous tranexamic acid (TXA) infusion DRUG

Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.

Also known as: Kapron®

Preoperative blood donation (n=30)

transfused only allogeneic blood. OTHER

Control group (n=30)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.

You may not qualify if:

• This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.

Sponsors & Collaborators

• Ain Shams University: lead

Results Point of Contact

• Title: Dr. Ibrahim Mamdouh Esmat
• Organization: Ain-Shams University Hospitals

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Lecturer of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 22, 2016
• Study Start: August 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share