The effect according to the injection type of tranexamic acid on reverse total shoulder arthroplasty

The effect according to the injection type of tranexamic acid on reverse total shoulder arthroplasty - prospective multi-center randomized control study -

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002073

Enrollment

102

Registered

2016-09-22

Start date

2016-08-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In this study, patients who underwent RTSA for the primary or secondary arthritis or irreparable massive rotator cuff tear or rotator cuff tear arthropathy were randomly assigned to three group

sodium chloride (Normal saline, abbreviation: N/S) is used via intravenously over a period from 5 to 10 minutes just before surgery. (When used rapidly, palpitation, chest discomfort or hypotension ra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who underwent reverse total shoulder arthroplasty, corresponding to 1 or more criteria described under. 1) Primary or secondary osteoarthritis of shoulder 2) Irreparable massive rotator cuff tear 3) Rotator cuff tear arthropathy

Exclusion criteria

Exclusion criteria: Patients corresponding to 1 or more criteria described under. 1) Patients with congenital or acquired coagulopathy 2) Patients with impaired kidney or liver before surgery. 3) Patients with severe cardiovascular disease. 4) Patients with a history of thromboembolism. 5) Patients with a history of seizures or convulsions. 6) Patients with a history of cerebral hemorrhage or thrombosis. 7) Patients with significantly low preoperative hemoglobin level.(female <11g>/dL, male <12g>/dL) 8) In case of fracture or revision surgery or severe deformity which can't be corrected with typical surgical method. 9) Patients who use the medication contraindicated in combination with tranexamic acid. 10) Patients with impaired sense of color acceptance. 11) Patients who treated with a female hormone therapy currently. 12) Patients with hypersensitivity reactions in medication or drug ingredients which used at clinical trial.

Design outcomes

Primary

Measure	Time frame
Decreased amount of hemoglobin level of postoperative 1 day (Preoperative hemoglobin level - postoperative 1 day hemoglobin level)	—

Secondary

Measure	Time frame
Amount of drain output;Estimated blood loss by Good and Nadler's formula;Transfusion rate	—

Countries

Korea, Republic of

Contacts

Public ContactJi Hyun Yeo

Seoul National University Bundang Hospital

wlgusdu@naver.com+82-31-787-7197

Outcome results