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Can a point of care, whole blood test, predict clotting complications after total hip and knee replacement surgery?

Use of preoperative rotational thromboelastography (ROTEM) assays to predict postoperative thrombotic complications following total hip and knee arthroplasty in overweight and obese patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000825550
Acronym
RETHInK-O
Enrollment
354
Registered
2015-08-11
Start date
2016-06-27
Completion date
2021-08-16
Last updated
2023-03-20

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

Conditions

None listed

Brief summary

This primary aim of this study is to determine if preoperative hypercoagulability, identified by ROTEM analysis, can predict postoperative thrombotic complications in overweight and obese patients undergoing elective lower limb joint replacements. Secondary aims: 1. To develop clinical threshold with ROTEM parameters to identify high risk patients with increased body mass index and/or waist circumference. 2. To monitor coagulation changes with ROTEM assays and platelet function with Multiplate analyser, preoperatively and postoperatively, in this cohort of patients. 3. To assess the sensitivity of the ROTEM assay to predict high-risk patients stratified according to body mass index and waist circumference.

Interventions

Preoperative and postopeartive ROTEM assays will be used detect hypercoagulability defined by the presence of rapid clot formation (evidenced by a shortened clotting time or clot formation time, increased alph angle) and/or increased clot strength (evidenced by high maximum clot firmness) in whole blood. Blood will be collected in a 3.5 mL citrated tube and 3 mL hirudin tube for ROTEM and multiplate analysis, respectively. These samples will be taken immediately prior to surgery, in the immediat

Preoperative and postopeartive ROTEM assays will be used detect hypercoagulability defined by the presence of rapid clot formation (evidenced by a shortened clotting time or clot formation time, increased alph angle) and/or increased clot strength (evidenced by high maximum clot firmness) in whole blood. Blood will be collected in a 3.5 mL citrated tube and 3 mL hirudin tube for ROTEM and multiplate analysis, respectively. These samples will be taken immediately prior to surgery, in the immediate post-operative period, and on days 1 and 3 post-operatively. The results of the ROTEM and multiplate investigations will not alter patient treatment. Patients will be commenced onThe Prince Charles Hospital venous thromboembolic prophylactic pathway which involves TED stockings, sequential compression devices, and either anticoagulants or aspirin

Sponsors

The Prince Charles Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective primary hip or knee replacement surgery with a BMI greater than/equal to 25 kg/m2 or waist circumference greater than/equal to 94 cm for males or 80 cm for females.

Exclusion criteria

1) Known history of thrombophilia (2) other possible causes of hypercoagulability namely active malignancy, prolonged bed rest, oral contraceptive pills, hormone replacement therapy, previous history of VTE and nephrotic syndrome (3) other disorders that would require postoperative anticoagulation such as cardiac valves/patients on long-term anticoagulation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026