Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs

NCT07309848 | Recruiting

• 1 other identifier: W25.034
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 7

Brief Summary

This study looks at patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. In many hospitals, surgery for these patients is delayed because of concerns about bleeding, but waiting longer can also increase risks such as complications and longer hospital stays. The purpose of this study is to find out whether operating within 24 hours is as safe as delaying surgery beyond 24 hours. Specifically, the investigators want to know if early surgery does not lead to a higher need for blood transfusions compared to delayed surgery.

Conditions

Blood Transfusion; Hip Fracture Surgeries; Geriatric; Bleeding Complications; Bleeding as Surgical Complication (Treatment); Bleeding; Blood Transfusions; Blood Transfusion Complication; Direct Oral Anticoagulants (DOACs)

Keywords

natural experiment; doac; direct oral anticoagulant; hip fracture; geriatric; surgery; bleeding; blood transfusion; early; delayed

Outcome Measures

Primary Outcomes (1)

• Number of participants receiving a postoperative blood transfusion

  Receiving one or more units of packed red blood cells in the postoperative period during hospitalization

  From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively)

Secondary Outcomes (36)

• Number of participants receiving a preoperative blood transfusion

  From emergency department presentation until start of surgery (up to 7 days preoperatively)

• Number of packed red blood cells administered postoperatively

  From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively)

• Number of packed red blood cells administered preoperatively

  From emergency department presentation until start of surgery (up to 7 days preoperatively)

• Surgical duration in minutes

  During surgery/procedure

• Intraoperative blood loss in milliliteres

  During surgery

Study Arms (2)

Early surgery

Surgery within 24 hours after last DOAC intake

Delayed surgery

Surgery after more than 24 hours after last DOAC intake

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from patients admitted with an isolated hip fracture to one of seven Dutch level 2 trauma centers. All patients are routinely treated according to local hospital protocols, which differ in surgical timing policies for patients on direct oral anticoagulants. This natural variation provides the basis for the study cohorts (\<24h vs \>24h to surgery).

You may qualify if:

• Isolated hip fracture classified as AO/OTA 31A or 31B requiring surgical intervention.
• Current DOAC use with the last dose taken ≤24 hours before emergency department (ED) presentation

You may not qualify if:

• Pathologic or periprosthetic hip fractures.
• Fracture sustained \>24 hours before ED presentation.
• Inter-hospital transfer.
• Hematologic disorders (e.g., thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, leukemia).
• Use of a non-EMA-approved DOAC (e.g., betrixaban).

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (7)

Ziekenhuisgroep Twente Hospital

Almelo, Netherlands

RECRUITING

Onze Lieve Vrouw Gasthuis Hospital

Amsterdam, Netherlands

RECRUITING

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Deventer Hospital

Deventer, Netherlands

RECRUITING

Martini Hospital

Groningen, Netherlands

RECRUITING

Diakonessenhuis Hospital

Utrecht, Netherlands

RECRUITING

St. Antonius Hospital

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Transfusion Reaction; Hip Fractures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Henk Jan Schuijt, MD, PhD

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Schiepers, MD

CONTACT

+31637557472; t.schiepers@antoniusziekenhuis.nl

Henk Jan Schuijt, MD, PhD

CONTACT

+31651915397; h.j.schuijt@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 30, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available beginning 6 months after publication of the primary results and will remain available for a minimum of 5 years thereafter. Requests submitted beyond this period will be considered on a case-by-case basis depending on data availability and institutional policies.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers upon reasonable request. Researchers must submit a methodologically sound proposal describing the planned analyses, which will be reviewed by the study steering committee for scientific merit, feasibility, and consistency with the study objectives. Approval will require signing a data sharing agreement that specifies conditions for appropriate use, data security, and compliance with privacy regulations. Requests can be submitted to the coordinating investigator at St. Antonius Hospital, Utrecht, who will coordinate review and approval.

Locations

NL (7)