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

NCT04614090 | Completed

• 1 other identifier: Leif Mattisson
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trochanteric Hip Fractures; Warfarin Medication; Early Surgery

Keywords

Hip fracture; Surgical treatment; Warfarin; Anticoagulation treatment; Intramedullary nailing

Outcome Measures

Primary Outcomes (10)

• Transfusion rates

  Hb value (g/dl)

  Pre-surgery

• Transfusion rates

  Transfusion rate (n)

  Pre-surgery

• Transfusion rates

  Hb value (g/dl)

  During the surgery

• Transfusion rates

  Transfusion rate (n)

  During the surgery

• Transfusion rates

  Hb value (g/dl)

  2-4 days after the surgery

• Transfusion rates

  Transfusion rate (n)

  2-4 days after the surgery

• adverse events

  Number of patients with a myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, sepsis, pneumonia, urinary tract infection, pressure ulcer, or any adverse events.

  Immediately after the surgery

• mortality

  The number of deaths

  Immediately after the surgery

• mortality

  The number of deaths

  30-days after the surgery

• mortality

  The number of deaths

  1 year after the surgery

Study Arms (2)

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)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients on warfarin, with low-energi trauma, \>60years, mean 86 years Op at Stockholm South General Hospital (södersjukhuset) between (Jan 1,2011 - Dec 31,2014) Follow-up 1 year, all pat op within 24 hours from hospital arrival to the surgery. Operated with Intramedullary nail due to unstable intertrochanteric (OTA/AO 31A2, A3) or Subtrochanteric fracture (OTA/AO 32A,32B,32C).

You may not qualify if:

• Pathological fracture
• Late presentation to the hospital
• Other injuries

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, Sjukhusbacken 10, 11883, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29945596 RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Leif Mattisson

  Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Orthopaedic Surgeon MD.,Ph.D.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 3, 2020
• Study Start: October 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: June 26, 2018
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

SE (1)