The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO
NCT ID: NCT03823417
Last Updated: 2019-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-07-31
2019-07-23
Brief Summary
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As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. placebo i.e. saline 0.9% (intravenous injection) (Control Group) or
2. intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
TREATMENT
TRIPLE
Study Groups
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Normal saline placebo
the participant will get saline 0.9% intravenous infusion for the duration of the surgery
Normal saline
Normal saline infusion
Intravenous Tranexamic acid
Intravenous TXA will be given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
Tranexamic Acid
Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
Interventions
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Tranexamic Acid
Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
Normal saline
Normal saline infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 13-35 years
* Scheduled for primary unilateral PAO +/- arthroscopy
Exclusion Criteria
* Major hepatic, renal, or vascular disorder
* Active Thromboembolic disorder
* Color vision defect
* TXA allergy
* Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)
* Ethical and/or religious objection to receiving blood products
* International patients
* Patients undergoing revision surgery
* Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy
13 Years
35 Years
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Susan Goobie
Associate Professor of Anaesthesiology, Harvard Medical School Associate in Perioperative Anesthesia, Boston Children's Hospital Clinical Director, Pharmacokinetics Laboratory.
Principal Investigators
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Susan Goobie, MD, FRPCP
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston children hospital
Boston, Massachusetts, United States
Countries
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References
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Maruyama M. CORR Insights((R)): Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Nov;473(11):3602-3. doi: 10.1007/s11999-015-4455-y. Epub 2015 Sep 9. No abstract available.
Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.
Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.
Wingerter SA, Keith AD, Schoenecker PL, Baca GR, Clohisy JC. Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Aug;473(8):2639-43. doi: 10.1007/s11999-015-4334-6. Epub 2015 May 20.
Goobie SM, Gallagher T, Gross I, Shander A. Society for the advancement of blood management administrative and clinical standards for patient blood management programs. 4th edition (pediatric version). Paediatr Anaesth. 2019 Mar;29(3):231-236. doi: 10.1111/pan.13574.
Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.
Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.
Goobie SM, Frank SM. Tranexamic Acid: What Is Known and Unknown, and Where Do We Go From Here? Anesthesiology. 2017 Sep;127(3):405-407. doi: 10.1097/ALN.0000000000001788. No abstract available.
Other Identifiers
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IRB-P00030426
Identifier Type: -
Identifier Source: org_study_id
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