Impact of Intraoperative Tranexamic Acid Administration on Postoperative Outcomes Following Total Hip Arthroplasty

Impact of Intraoperative Tranexamic Acid Administration on Postoperative Outcomes Following Total Hip Arthroplasty - SHAPE-TXA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00041024

Enrollment

200

Registered

2026-07-23

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

The postoperative course of patients following elective total hip arthroplasty is investigated.

Interventions

Group 1: Patients receiving intraoperative tranexamic acid (TXA): Patients will undergo standardized surgery and postoperative care according to routine clinical practice, including mobilization, anal

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing elective total hip arthroplasty, using the dorsolateral surgical approach only, with an ASA-physical status classification of 1+2+3.

Exclusion criteria

Exclusion criteria: ASA-physical status classification 4

Design outcomes

Primary

Measure	Time frame
Assessment of postoperative pain at rest and during mobilization in patients with and without intraoperative administration of tranexamic acid (TXA), using the Numeric Rating Scale (NRS, 0–10). Pain assessments will be performed on postoperative days 1, 3, and 5. The primary comparison will be based on the NRS score on postoperative day 5. Pain will be assessed in a standardized manner by patient self-report using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain, both at rest and during mobilization.	—

Measure

Time frame

Assessment of postoperative pain at rest and during mobilization in patients with and without intraoperative administration of tranexamic acid (TXA), using the Numeric Rating Scale (NRS, 0–10). Pain assessments will be performed on postoperative days 1, 3, and 5. The primary comparison will be based on the NRS score on postoperative day 5. Pain will be assessed in a standardized manner by patient self-report using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain, both at rest and during mobilization.

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Secondary

Measure	Time frame
Assessment of postoperative edema development, the extent of peri-incisional ecchymosis, and intraoperative blood loss in patients with and without intraoperative administration of tranexamic acid (TXA). Postoperative edema will be assessed by standardized circumference measurements of the operated leg at six predefined anatomical landmarks (20 cm and 10 cm proximal to the knee joint space, at the level of the knee joint space, 15 cm distal to the knee joint space, at the level of the ankle joint, and at the metatarsal heads). Measurements will be performed preoperatively and on postoperative days 3 and 5. The extent of peri-incisional ecchymosis will be determined by standardized metric measurements on postoperative days 3 and 5. Intraoperative blood loss will be recorded once during surgery based on the operative documentation.	—

Measure

Time frame

Assessment of postoperative edema development, the extent of peri-incisional ecchymosis, and intraoperative blood loss in patients with and without intraoperative administration of tranexamic acid (TXA). Postoperative edema will be assessed by standardized circumference measurements of the operated leg at six predefined anatomical landmarks (20 cm and 10 cm proximal to the knee joint space, at the level of the knee joint space, 15 cm distal to the knee joint space, at the level of the ankle joint, and at the metatarsal heads). Measurements will be performed preoperatively and on postoperative days 3 and 5. The extent of peri-incisional ecchymosis will be determined by standardized metric measurements on postoperative days 3 and 5. Intraoperative blood loss will be recorded once during surgery based on the operative documentation.

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Countries

Germany

Contacts

Public ContactJens Anders

Kliniken Dr. Erler gGmbH

j.anders@erler-klinik.de+49 911/ 27 28-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026