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

Early Surgery Clinical Trial

Official title:

Is Fast Reversal and Early Surgery (Within 24 h) in Patients on Warfarin Medication With Trochanteric Hip Fractures Safe: A Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614090
• Other study ID #: Leif Mattisson
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: June 26, 2018

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 26, 2018
• Est. primary completion date: February 1, 2018
• Gender: All
• Age group: 60 Years and older

Eligibility

Exclusion Criteria:

• Pathological fracture

• Late presentation to the hospital

• Other injuries

Related Conditions & MeSH terms

• Early Surgery
• Fractures, Bone
• Hip Fractures
• Trochanteric Hip Fractures
• Warfarin Medication

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm	Sjukhusbacken 10

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

References & 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/s12891-018-21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion rates	Hb value (g/dl)	Pre-surgery
Primary	Transfusion rates	Transfusion rate (n)	Pre-surgery
Primary	Transfusion rates	Hb value (g/dl)	During the surgery
Primary	Transfusion rates	Transfusion rate (n)	During the surgery
Primary	Transfusion rates	Hb value (g/dl)	2-4 days after the surgery
Primary	Transfusion rates	Transfusion rate (n)	2-4 days after the surgery
Primary	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
Primary	mortality	The number of deaths	Immediately after the surgery
Primary	mortality	The number of deaths	30-days after the surgery
Primary	mortality	The number of deaths	1 year after the surgery