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Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Primary Purpose

Intraoperative Blood Loss, Pediatric, Orthopedic Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Tranexamic acid

caudal epidural block

Placebo

About this trial

This is an interventional prevention trial for Intraoperative Blood Loss

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I - II
Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Exclusion Criteria:

Patient's guardian refusal to participate in the study.
Children known to have pre-existing bleeding or coagulation disorders.
Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
History of epilepsy.
History of renal insufficiency or failure

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

T group

TC group

C group

P group

Arm Description

each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision.

each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.

each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.

participants will receive the regular standard care without adding tranexamic acid or caudal epidural block

Outcomes

Primary Outcome Measures

amount of intraoperative blood loss

calculated from the fall in red blood cell volume

Secondary Outcome Measures

Rate of blood transfusion

either intraoperative or postoperative blood transfusion

Incidence of adverse effects or complications of TXA

e.g. thromboembolic events or perioperative seizures will be managed and recorded

length of hospital stay

readiness for hospital discharge

Full Information

NCT ID

NCT04811313

First Posted

March 19, 2021

Last Updated

March 19, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04811313

Brief Title

Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Official Title

Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

Detailed Description

the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited. We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraoperative Blood Loss, Pediatric, Orthopedic Disorder

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

T group

Arm Type

Active Comparator

Arm Description

each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision.

Arm Title

TC group

Arm Type

Active Comparator

Arm Description

Arm Title

C group

Arm Type

Active Comparator

Arm Description

each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.

Arm Title

P group

Arm Type

Placebo Comparator

Arm Description

participants will receive the regular standard care without adding tranexamic acid or caudal epidural block

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Other Intervention Name(s)

Kapron

Intervention Description

patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA

Intervention Type

Procedure

Intervention Name(s)

caudal epidural block

Other Intervention Name(s)

bupivacaine 0.25%

Intervention Description

regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

participants will receive standard care but neither TXA nor caudal epidural block

Primary Outcome Measure Information:

Title

amount of intraoperative blood loss

Description

calculated from the fall in red blood cell volume

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Rate of blood transfusion

Description

either intraoperative or postoperative blood transfusion

Time Frame

24 hours

Title

Incidence of adverse effects or complications of TXA

Description

e.g. thromboembolic events or perioperative seizures will be managed and recorded

Time Frame

24 hours

Title

length of hospital stay

Description

readiness for hospital discharge

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I - II Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies. Exclusion Criteria: Patient's guardian refusal to participate in the study. Children known to have pre-existing bleeding or coagulation disorders. Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys History of epilepsy. History of renal insufficiency or failure

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shimaa A Hassan, M.D.

Phone

01002953253

shimaa.abbas@med.aun.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Amira A Abdel-rahman, M.B.B.CH

Phone

01002595850

amiraali441994@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr M Sleem, M.D.

Organizational Affiliation

Assiut University

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

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