Fast Reversal of Warfarin and Early Surgery in Patients With Trochanteric Hip Fracture A Case-control Study

NCT ID: NCT04614090

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trochanteric Hip Fractures Warfarin Medication Early Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

99 warfarin patients

warfarin patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. All patients on warfarin were reversed if necessary to INR≤1.5 before surgery using vitamin K and/or four-factor prothrombin complex concentrate (PCC)

No interventions assigned to this group

99 patients without anticoagulants

As a 1:1 ratio control group matched for age, gender and surgical implant. All patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Pathological fracture
* Late presentation to the hospital
* Other injuries
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leif Mattisson

Senior Consultant Orthopaedic Surgeon MD.,Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leif Mattisson

Role: PRINCIPAL_INVESTIGATOR

Stockholm South General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Södersjukhuset

Stockholm, Sjukhusbacken 10, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Mattisson L, Lapidus LJ, Enocson A. Is fast reversal and early surgery (within 24 h) in patients on warfarin medication with trochanteric hip fractures safe? A case-control study. BMC Musculoskelet Disord. 2018 Jun 26;19(1):203. doi: 10.1186/s12891-018-2126-3.

Reference Type RESULT
PMID: 29945596 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Leif Mattisson

Identifier Type: -

Identifier Source: org_study_id